Associations between the cortisol awakening response and patient-evaluated stress and mood instability in patients with bipolar disorder: an exploratory study

Abstract Objective The Cortisol Awakening Response (CAR) measured as the transient increase in cortisol levels following morning awakening appears to be a distinct feature of the HPA axis. Patients with bipolar disorder (BD) experience daily stress, mood instability (MI) and studies have shown disrupted HPA-axis dynamics. Aims: to evaluate (1) patient-evaluated stress against the CAR, (2) associations between the CAR and mood symptoms, and (3) the effect of smartphone-based treatment on the CAR. Methods Patients with BD (n = 67) were randomized to the use of daily smartphone-based monitoring (the intervention group) or to the control group for six months. Clinically rated symptoms according to the Hamilton Depression Rating Scale 17-items (HDRS), the Young Mania Rating Scale (YMRS), patient-evaluated perceived stress using Cohen’s Perceived Stress Scale (PSS) and salivary awakening cortisol samples used for measuring the CAR were collected at baseline, after three and six months. In the intervention group, smartphone-based data on stress and MI were rated daily during the entire study period. Results Smartphone-based patient-evaluated stress (B: 134.14, 95% CI: 1.35; 266.92, p = 0.048) and MI (B: 430.23, 95% CI: 52.41; 808.04, p = 0.026) mapped onto increased CAR. No statistically significant associations between the CAR and patient-evaluated PSS or the HDRS and the YMRS, respectively were found. There was no statistically significant effect of smartphone-based treatment on the CAR. Conclusion Our data, of preliminary character, found smartphone-based patient-evaluations of stress and mood instability as read outs that reflect CAR dynamics. Smartphone-supported clinical care did not in itself appear to disturb CAR dynamics.

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Daily electronic self-monitoring in bipolar disorder using smartphones – the MONARCA I trial: a randomized, placebo-controlled, single-blind, parallel group trial

Psychological Medicine ◽

10.1017/s0033291715000410 ◽

2015 ◽

Vol 45 (13) ◽

pp. 2691-2704 ◽

Cited By ~ 77

Author(s):

M. Faurholt-Jepsen ◽

M. Frost ◽

C. Ritz ◽

E. M. Christensen ◽

A. S. Jacoby ◽

...

Keyword(s):

Bipolar Disorder ◽

Depressive Symptoms ◽

Rating Scale ◽

Group Analysis ◽

Intervention Group ◽

Patient Acceptance ◽

Control Group ◽

Self Monitoring ◽

Manic Symptoms ◽

Depressive And Manic Symptoms

BackgroundThe number of studies on electronic self-monitoring in affective disorder and other psychiatric disorders is increasing and indicates high patient acceptance and adherence. Nevertheless, the effect of electronic self-monitoring in patients with bipolar disorder has never been investigated in a randomized controlled trial (RCT). The objective of this trial was to investigate in a RCT whether the use of daily electronic self-monitoring using smartphones reduces depressive and manic symptoms in patients with bipolar disorder.MethodA total of 78 patients with bipolar disorder according to ICD-10 criteria, aged 18–60 years, and with 17-item Hamilton Depression Rating Scale (HAMD-17) and Young Mania Rating Scale (YMRS) scores ≤17 were randomized to the use of a smartphone for daily self-monitoring including a clinical feedback loop (the intervention group) or to the use of a smartphone for normal communicative purposes (the control group) for 6 months. The primary outcomes were differences in depressive and manic symptoms measured using HAMD-17 and YMRS, respectively, between the intervention and control groups.ResultsIntention-to-treat analyses using linear mixed models showed no significant effects of daily self-monitoring using smartphones on depressive as well as manic symptoms. There was a tendency towards more sustained depressive symptoms in the intervention group (B = 2.02, 95% confidence interval −0.13 to 4.17, p = 0.066). Sub-group analysis among patients without mixed symptoms and patients with presence of depressive and manic symptoms showed significantly more depressive symptoms and fewer manic symptoms during the trial period in the intervention group.ConclusionsThese results highlight that electronic self-monitoring, although intuitive and appealing, needs critical consideration and further clarification before it is implemented as a clinical tool.

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The effect of smartphone-based monitoring on illness activity in bipolar disorder: the MONARCA II randomized controlled single-blinded trial

Psychological Medicine ◽

10.1017/s0033291719000710 ◽

2019 ◽

Vol 50 (5) ◽

pp. 838-848 ◽

Cited By ~ 18

Author(s):

Maria Faurholt-Jepsen ◽

Mads Frost ◽

Ellen Margrethe Christensen ◽

Jakob E. Bardram ◽

Maj Vinberg ◽

...

Keyword(s):

Quality Of Life ◽

Bipolar Disorder ◽

Perceived Stress ◽

Intervention Group ◽

Control Group ◽

Manic Symptoms ◽

Randomized Controlled ◽

Depressive Episodes ◽

Depressive And Manic Symptoms

AbstractBackgroundRecently, the MONARCA I randomized controlled trial (RCT) was the first to investigate the effect of smartphone-based monitoring in bipolar disorder (BD). Findings suggested that smartphone-based monitoring sustained depressive but reduced manic symptoms. The present RCT investigated the effect of a new smartphone-based system on the severity of depressive and manic symptoms in BD.MethodsRandomized controlled single-blind parallel-group trial. Patients with BD, previously treated at The Copenhagen Clinic for Affective Disorder, Denmark and currently treated at community psychiatric centres, private psychiatrists or GPs were randomized to the use of a smartphone-based system or to standard treatment for 9 months. Primary outcomes: differences in depressive and manic symptoms between the groups.ResultsA total of 129 patients with BD (ICD-10) were included. Intention-to-treat analyses showed no statistically significant effect of smartphone-based monitoring on depressive (B = 0.61, 95% CI −0.77 to 2.00, p = 0.38) and manic (B = −0.25, 95% CI −1.1 to 0.59, p = 0.56) symptoms. The intervention group reported higher quality of life and lower perceived stress compared with the control group. In sub-analyses, the intervention group had higher risk of depressive episodes, but lower risk of manic episodes compared with the control group.ConclusionsThere was no effect of smartphone-based monitoring. In patient-reported outcomes, patients in the intervention group reported improved quality of life and reduced perceived stress. Patients in the intervention group had higher risk of depressive episodes and reduced risk of manic episodes. Despite the widespread use and excitement of electronic monitoring, few studies have investigated possible effects. Further studies are needed.

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The effectiveness of discharge planning and range of motion (ROM) training in increasing muscle strength of nonhemorrhagic stroke patients

GHMJ (Global Health Management Journal) ◽

10.35898/ghmj-23271 ◽

2018 ◽

Vol 2 (3) ◽

pp. 57

Author(s):

Mohamat Iskandar

Keyword(s):

Muscle Strength ◽

Range Of Motion ◽

Rating Scale ◽

Discharge Planning ◽

Intervention Group ◽

Sampling Technique ◽

Control Group ◽

Planning Program ◽

Stroke Patients ◽

Central Java

Background: Non-hemorrhagic stroke patients experience hemiparesis, an improper handling results in joint contractures. Discharge planning combined with a range of motion (ROM) training given to patients and their families are expected to improve muscle strength in patients after returning from the hospital. Aims: This study is to identify the effectiveness of discharge planning in increasing muscle strength. Methods: This is a quasi-experimental study with a pre-posttest design. A total of 34 respondents were selected by cluster random sampling technique, from RAA Soewondo Pati General Hospital of Pati, Central Java, Indonesia. The respondents were divided equally into two groups; an intervention group (N = 17) was given a discharge planning program together with stroke information and range of motion (ROM) training while the control group (N = 17) received a standard discharge planning available in the hospital. Further, Muscle Rating Scale (MRS) was employed to assess the muscle strength on the 2nd, 7th, and 14th day after discharge planning presented to the nonhemorrhagic stroke patients. Results: This present study clearly acknowledges the standard discharge planning program available in the hospital improve the muscle strength of the upper and lower extremity in the nonhemorrhagic stroke patients just 2nd day after the care (pretest), and the significant improvement was observed until the day 14. Moreover, combining the care with ROM training at the intervention group faster the recovery and the muscle strength improved significantly at the 7th day and continue increase at the day 14. Looking to the muscle strength since the 2nd day to the day 14, respectively the muscle strength of upper and lower limb at the control group improved at the point of 0.588 and 0.882, while at the group received the ROM training reached the value of 1.472 and 1.412. Conclusions: The ROM training combined to the current discharge planning program will faster the muscle strength recovery of the nonhemorrhagic stroke patients. This research provide insight how family plays important role to the success in monitoring the rehabilitation and recovery progress.

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Efficacy of ‘Foundations’, a Digital Mental Health App to Improve Mental Well-Being, during COVID-19: A Proof-of-Principle Randomised Controlled Trial (Preprint)

10.2196/preprints.30976 ◽

2021 ◽

Author(s):

Silvina Catuara-Solarz ◽

Bartlomiej Skorulski ◽

Inaki Estella ◽

Claudia Avella-Garcia ◽

Sarah Shepherd ◽

...

Keyword(s):

Mental Health ◽

Perceived Stress ◽

Intervention Group ◽

Well Being ◽

Self Report ◽

World Health ◽

Randomised Control Trial ◽

Control Group ◽

Mental Well Being ◽

Proof Of Principle

BACKGROUND Against a long-term trend of increasing demand, the COVID-19 pandemic has led to a global rise in common mental disorders. Now more than ever, there is an urgent need for scalable, evidence-based interventions to support mental well-being. OBJECTIVE The aim of this proof-of-principle study was to evaluate the efficacy of a mobile-based app in adults with self-reported symptoms of anxiety and stress in a randomised control trial that took place during the first wave of the COVID-19 pandemic in the UK. METHODS Adults with mild to severe anxiety and moderate to high levels of perceived stress were randomised to either the intervention or control arm. Participants in the intervention arm were given access to the app, Foundations, for the duration of the 4-week study. All participants were required to self-report a range of validated measures of mental well-being (10-item Connor-Davidson Resilience scale [CD-RISC-10]; 7-item Generalised Anxiety Disorder scale [GAD-7]; Office of National Statistics Four Subjective Well-being Questions [ONS-4]; World Health Organisation-5 Well-Being Index [WHO-5]) and sleep (Minimal Insomnia Scale [MISS]) at baseline and weeks 2 and 4; and, in addition, on perceived stress weekly (10-item Perceived Stress Score [PSS]). RESULTS 136 participants completed the study and were included in the final analysis. The intervention group (n=62) showed significant improvements compared to the control group (n=74) on measures of anxiety (GAD-7 score, delta from baseline to week 2 in the intervention group: -1.35 [SD 4.43]; control group: -0.23 [SD 3.24]; t134= 1.71 , P=.04), resilience (CD-RISC score, delta from baseline to week 2 in the intervention group: 1.79 [± SD 4.08]; control group: -0.31 [± SD 3.16]; t134 -3.37, P<.001), sleep (MISS score, delta from baseline to week 2 in the intervention group: -1.16 [± SD 2.67]; control group: -0.26 [± SD 2.29]; t134= 2.13, P=.01), and mental well-being (WHO-5 score, delta from baseline to week 2 in the intervention group: 1.53 [5.30]; control group: -0.23 [± SD 4.20]; t134= -2.16, P=.02) within 2 weeks of using Foundations, with further improvements emerging at week 4. Perceived stress was also reduced within the intervention group, although the results did not reach statistical significance relative to the control group (PSS score, delta from baseline to week 2 in the intervention group: -2.94 [± SD 6.84]; control group: -2.05 [± SD 5.34]; t134= 0.84, P=.20). CONCLUSIONS This study provides proof-of-principle that the digital mental health app, Foundations, can improve measures of mental well-being, anxiety, resilience, and sleep within 2 weeks of use, with greater effects after 4 weeks. It therefore offers potential as a scalable, cost-effective, and accessible solution to enhance mental well-being, even during times of crisis such as the COVID-19 pandemic.

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Assessment of Acupuncture and Moxibustion Effects on the Electrophysiological Properties of the Ulnar Nerve: A Nerve Conduction Study

Integrative Medicine International ◽

10.1159/000490176 ◽

2018 ◽

Vol 4 (3-4) ◽

pp. 198-207 ◽

Cited By ~ 2

Author(s):

Sónia Chan ◽

Sérgio Ferreira ◽

Bruno Ramos ◽

Maria João Santos ◽

Luís Carlos Matos ◽

...

Keyword(s):

Electrical Stimulation ◽

Ulnar Nerve ◽

Rating Scale ◽

Intervention Group ◽

Maximum Amplitude ◽

Numeric Rating Scale ◽

Control Group ◽

Reaction Velocity ◽

Electrophysiological Properties ◽

Acupuncture And Moxibustion

Background/Aims: Acupuncture and moxibustion, when used together, have act mechanically and thermally on treated reflexological areas. The main goal of this work was to evaluate the effects of acupuncture and moxibustion on the electrophysiological properties of the ulnar nerve. Methods: Electrical stimulation was applied to the ulnar nerve above the epicondyle of 28 volunteers. A 20-V potential was applied, and after each 10 impulses it was increased by 10 V, up to a maximum of 80 V. At 20 and 80 V, the participants were asked to rate the discomfort from 0 to 10 on a Numeric Rating Scale for pain. After the first stimulation and data collection, the control group rested for 6 min, while the intervention group was submitted to acupuncture and moxibustion on Lingdao (HT 4). Following this period of time, a second electrical stimulation was performed on both groups. Results: The discomfort was greater in the intervention group during the second stimulation. The stimulus required to achieve the maximum amplitude decreased, but the changes were only statistically significant in the intervention group (p = 0.006). An increase in latency and a decrease in reaction velocity were noticed between the first and the second stimulation for both groups; however, only the control group presented statistically significant differences (p = 0.018 and p = 0.022, respectively). Conclusions: Acupuncture and moxibustion on HT 4 increased the electrical sensitivity, decreased the stimulus intensity to achieve the maximum amplitude, and avoided a significant increase in latency and decrease in reaction velocity in two consecutive electrical stimulations.

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Efektivitas Mendengarkan Murotal Al-Qur’an terhadap Derajat Insomnia pada Lansia di Selter Dongkelsari Sleman Yogyakarta

Jurnal Ners dan Kebidanan Indonesia ◽

10.21927/jnki.2015.3(1).20-25 ◽

2016 ◽

Vol 3 (1) ◽

pp. 20

Author(s):

Fatma Siti Fatimah ◽

Zulkhah Noor

Keyword(s):

Rating Scale ◽

Intervention Group ◽

Relaxation Effect ◽

Psychological Problem ◽

T Test ◽

Control Group ◽

Paired Samples ◽

Post Test ◽

The Mean ◽

Traumatic Effect

<p>Merapi eruption in 2010 in Yogyakarta caused people losing their homes and triggering traumatic effect. Elderly is one of victims that vulnerable to psychological problem. The common psychological late respons due to disaster is insomnia. The impacts of insomnia are decrease the level of immunity, increase mortality and decrease quality of life, thus it needs to be solved. One of the solution is by listening murotal Al-Qur’an that will give relaxation effect. The study was aimed to know the effectiveness of listening murotal Al-Qur’an to the changing of elderly insomnia level in shelter Dongkelsari, Sleman, Yogyakarta.The design of study was a quasy experimental pre post test with control group. Technique of taking sample was probability sampling and it was found that there were 37 elderly who live in shelter Dongkelsari Sleman Yogyakarta that fulfilled the inclusion criteria. Research instrument which was used to measure insomnia level is KSPBJ questionnaire rating scale and to listen for murotal Al-Qur’an (Ar-Rahmaan) was used laptop and speaker. The duration of listening murotal Al-Qur’an was 8 days with 12 minutes for each day. Data analysis was used paired samples t test and independent samples t test. The level of insomnia for control group pre test and post test is in moderate insomnia by the mean ± SD each of them is 9.3 ± 3.7 and 10.3 ± 3.4 (p>0.05) and for intervention group there was a changing from moderate insomnia to mild insomnia by the mean ± SD each of them is 10.9 ± 3.6 and 8.2 ± 4.2 (p<0.05). There was a significant differences between the intervention group and control group by the mean ± SD each of them is -2.8 ± 3.0 and 0.9 ± 3.5 (p<0.05). In conclusion, listening murotal Al-Qur’an was effective to reduce elderly insomnia level in shelter Dongkelsari Sleman Yogyakarta.</p>

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Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab467 ◽

2021 ◽

Author(s):

Angela Chu ◽

Tyler M Rose ◽

Danielle A Gundrum ◽

Tressa E McMorris ◽

Eytan A Klausner ◽

...

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Intervention Period ◽

Entire Study ◽

Positive Effects ◽

Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

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The Effect of Mindfulness-Based Stress Reduction Group Counseling on Psychological and Inflammatory Responses of the Women With Breast Cancer

Integrative Cancer Therapies ◽

10.1177/1534735420946819 ◽

2020 ◽

Vol 19 ◽

pp. 153473542094681

Author(s):

Motahareh Mirmahmoodi ◽

Parvin Mangalian ◽

Atefeh Ahmadi ◽

Mahlagha Dehghan

Keyword(s):

Breast Cancer ◽

Perceived Stress ◽

Stress Reduction ◽

Group Counseling ◽

Inflammatory Responses ◽

Intervention Group ◽

Control Group ◽

Significant Difference ◽

Reduction Group ◽

Mindfulness Based Stress Reduction

Introduction: Breast cancer is common among women and reduces their quality of life. The current study aimed to investigate the effectiveness of mindfulness-based stress reduction group counseling in alleviating psychological responses such as anxiety, depression, stress, and regulating laboratory tests including cortisol and C-reactive protein (CRP) in women with breast cancer. Methods: This randomized clinical trial was conducted based on convenience sampling. Participants were divided into 2 groups (control and intervention groups) with block randomization. The intervention group received mindfulness-based stress reduction group counseling during 8 weeks. The participants completed the Beck anxiety inventory, Beck-II depression inventory, and perceived stress scale before and after the intervention and their blood samples were taken to check their cortisol and CRP. Results: After the intervention, the MBSR group had significantly lower anxiety compared with the control group ( P < .001). No significant difference was found between the 2 groups in the reduction of perceived stress and depression ( P < .05). In addition, no significant difference was found between the 2 groups in CRP and cortisol levels after the intervention ( P > .05). Conclusion: The present study showed the effectiveness of mindfulness-based cognitive therapy in improving anxiety rather than the stress, depression, and inflammatory laboratory factors such as cortisol and CRP in women with breast cancer. Therefore, the psychological symptoms of these patients can be improved at different stages of treatment by providing this type of training.

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P5306Changes in health-behaviours of 15-year old girls depend on satisfaction with the prophylactic intervention program. Healthy Me Study

European Heart Journal ◽

10.1093/eurheartj/ehz746.0277 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

A Fijalkowska ◽

J Mazur ◽

A Dzielska ◽

H Nalecz ◽

W Ostrega ◽

...

Keyword(s):

Physical Activity ◽

Stress Level ◽

Vigorous Physical Activity ◽

Intervention Group ◽

Health Behaviours ◽

Smoking Prevention ◽

Control Group ◽

Entire Study ◽

Level Of Satisfaction ◽

Main Effect

Abstract Introduction Healthy Me (HM) interventional study was oriented on improvement of physical activity (PA) in 15-year old girls but also included component of eating habits, smoking prevention and personal competencies. Innovative elements of the project involved usage of fitness-band with continuous monitoring of PA and special dedicated smartphone apps. Purpose To assess the effectiveness of 1-year prophylactic intervention with the use of mobile technology in girls between 14 and 15 year of age, in relation to the level of their satisfaction with the program. Methods 1198 girls 14–15 years old from 48 randomly selected schools from all over Poland participated in the HM during 2017/2018 school year. Schools were randomized to full or partial intervention and control group, respectively 636, 277 and 285 girls. Questionnaire data from the beginning and the end of the HM regarding four factors (low PA, eating sweets, smoking and stress level) were analyzed. Mean changes (MC) calculated according to the definition given in table 1 were applied as outcome measure. Satisfaction with the program was assessed after 1 year of participation in the HM as low, average and high. General linear models with main effects were estimated and adjusted for initial level of each factor. Results At the beginning of the study 87% participants did not fulfill criteria for recommended PA, 9% smoked during last 30 days and 67% ate sweets more than ones per week. Mean stress level was 6.92±2.92 points. For the entire study group, the only significant change after 1 year intervention was lower frequency of eating sweets (p=0,007). However, the higher satisfaction with the study resulted in the significantly higher effectiveness of HM intervention (table 1). Mean changes in the analyzed factors Analyzed factor Range Mean change in entire group (SE) Mean change by level of satisfaction p1 p2 low (SE) average (SE) high (SE) Physical activity (MVPA) 0–7 days −0.076 (0.063) −0.396 (0.137) −0.147 (0.068) 0.261 (0.119) 0.001 0.068 Smoking-past 0 – never 0.039 (0.028) 0.270 (0.066) 0.034 (0.033) −0.004 (0.057) 0.002 0.067 6–30 days or more Eating sweets 0 – never −0.296 (0.045) −0.047 (0.101) −0.285 (0.050) −0.313 (0.086) 0.069 0.016 6 – every day more than once Stress Cohen scale 0–16 points 0.105 (0.090) 0.498 (0.211) 0.138 (0.105) −0.424 (0.183) 0.003 0.823 SE: standard error; MVPA: moderate to vigorous physical activity; p1: main effect of the level of satisfaction; p2: main effect of the intervention group. Conclusion Program that was dedicated for improvement of PA in teenage girls could also profitably influence other factors related to health behaviours and stress level in this group but intervention must be perceived by participants as rewarding. It seems, that attractiveness of interventional program design, increased by mobile technologies, is key for its effectiveness for teens. Acknowledgement/Funding National Health Program, Ministry of Health

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Efficacy of an antigravity treadmill on functional outcome in non-operatively treated pelvic fractures: a prospective pilot study

International Journal of Therapy and Rehabilitation ◽

10.12968/ijtr.2018.0057 ◽

2019 ◽

Vol 26 (11) ◽

pp. 1-9

Author(s):

Ralf Henkelmann ◽

Michael Schäfer ◽

Andreas Höch ◽

Christian Leps ◽

Martin Busse ◽

...

Keyword(s):

Pilot Study ◽

Gait Analysis ◽

Rating Scale ◽

Intervention Group ◽

Training Session ◽

Pelvic Fractures ◽

Control Group ◽

Gait Patterns ◽

Prospective Pilot Study ◽

Normal Gait

Background/Aims Treating pelvic fractures non-operatively is possible. The immobilisation stage of recovery requires different adjustment processes compared to those used in operative treatment. The aim of the present study was to prove the additional benefit an antigravity treadmill can have on patients with non-operatively treated pelvic fractures. Methods A prospective pilot study, including patients with non-operatively treated pelvic fractures as the intervention group and healthy volunteers as a control group, was undertaken. Patients of the intervention group participated in a training session with an antigravity treadmill every 3 days for a total of 40 days, in addition to physiotherapy, lymph drainage massage and manual therapy. Patients were evaluated using a dynamic gait index, and a numeric rating scale on three successive dates, to assess their pain. A standardised gait analysis was also carried out. Results The intervention group comprised 9 patients, while 33 patients made up the control group. All patients completed the protocols and experienced a significant decrease in pain and increase of mobility. Gait analysis showed that by the 40-day follow-up, patients in the intervention group had regained almost normal gait patterns when compared to the control group. At each time point, a significant improvement in patients' gait patterns could be seen. Conclusions The results concurred with previous studies, suggesting that the antigravity treadmill is safe and that recovery to almost normal gait patterns is possible, while the comparison to a healthy group strengthened the data. The present prospective study thus showed promising results regarding the efficacy of the antigravity treadmill, despite study limitations.

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