Pedometers alone do not increase mobility in inpatient rehabilitation: a randomized controlled trial

Objective: To test if pedometers, as a motivational tool, could affect mobility outcomes in inpatient rehabilitation. Design: Randomized controlled clinical trial. Setting: Subacute hospital rehabilitation unit in Australia. Participants: A total of 78 participants with reduced mobility and clinician-determined capacity to improve. Interventions: Both groups received usual care. For the intervention group, a pedometer was worn on the hip with the step count visible to participant and recorded daily on an exercise log. For the control group, a pedometer fixed shut was worn on the hip and they recorded estimated distances walked on an exercise log. Main measures: Primary outcome was functional mobility – De Morton Mobility Index. Secondary outcome measures were walking velocity, functional independence measure, time spent upright and daily step count. Results: Significant improvements over time ( P < 0.001) in functional mobility, comfortable walking velocity and functional independence measure were not influenced by the intervention. The daily average upright time (hours) in the first week of intervention was different ( P = 0.004) between the intervention group (median, interquartile range (IQR): 1.67, 1.77) compared to the control group (median, IQR: 1.12, 0.82). Conclusion: Pedometers as a motivational tool without targets do not improve functional mobility in this population. Pedometers may improve daily upright time in this setting.

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Effect of neuromuscular electrical stimulation on functional exercise capacity in patients undergoing cardiac surgery: A randomized clinical trial

Clinical Rehabilitation ◽

10.1177/02692155211070945 ◽

2021 ◽

pp. 026921552110709

Author(s):

Telma Cristina Fontes Cerqueira ◽

Manoel Luiz de Cerqueira Neto ◽

Lucas de Assis Pereira Cacau ◽

Amaro Afrânio de Araújo Filho ◽

Géssica Uruga Oliveira ◽

...

Keyword(s):

Cardiac Surgery ◽

Electrical Stimulation ◽

Postoperative Period ◽

Intervention Group ◽

Neuromuscular Electrical Stimulation ◽

Functional Independence Measure ◽

Rectus Femoris ◽

Functional Independence ◽

Control Group ◽

Electromyographic Activity

Objective To evaluate the effects of neuromuscular electrical stimulation on functional capacity of patients in the immediate postoperative period of cardiac surgery. Design A prospective, randomized controlled trial. Setting A cardiac surgery specialist hospital in Aracaju, Sergipe, Brazil. Subjects: Patients in the postoperative period of cardiac surgery. Intervention The control group received the conventional physiotherapy and the intervention group received neuromuscular electrical stimulation of the rectus femoris and gastrocnemius muscles bilaterally, applied for 60 min, twice a day for up to 10 sessions per patient, in the immediate postoperative period until postoperative day 5. Main measures The primary outcome was the distance walked, which was evaluated using the 6-min walk test on postoperative day 5. Secondary outcomes were gait speed, lactate levels, muscle strength, electromyographic activity of the rectus femoris and Functional Independence Measure, some of them evaluated on preoperative and postoperative period. Results Of 132 eligible patients, 88 patients were included and randomly allocated in two groups, and 45 patients were included in the analysis. No significant difference was found on the distance walked ( p = 0.650) between patients allocated in intervention group (239.06 ± 88.55) and control group (254.43 ± 116.67) as well as gait speed ( p = 0.363), lactate levels ( p = 0.302), knee extensor strength ( p = 0.117), handgrip strength ( p = 0.882), global muscle strength ( p = 0.104), electromyographic activity ( p = 0.179) and Functional Independence Measure ( p = 0.059). Conclusions Although the effects are still uncertain, the use of neuromuscular electrical stimulation carried out in five days didn't present any benefit on functional capacity of patients in the immediate postoperative period of cardiac surgery.

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EVALUATION OF EFFECTIVENESS OF AROGYA KASHAYAM-20 IN COVID-19 CASES - A RANDOMIZED CONTROLLED STUDY

10.31219/osf.io/au3ct ◽

2021 ◽

Author(s):

Umesh Shukla ◽

Nitin Ujjaliya

Keyword(s):

Controlled Trial ◽

Care Center ◽

Large Population ◽

Intervention Group ◽

Controlled Study ◽

Control Group ◽

Rt Pcr ◽

Randomized Controlled ◽

Group A ◽

Negative Conversion

Introduction: The characteristic clinical features of Covid-19 disease range between asymptomatic to mild-moderate symptoms. Studies suggest that a large population (80%) presents its asymptomatic or milder form. Remaining 20 percent, owing to severity of the diseases, need hospital-based care. Many treatment protocols and strategies have been promoted and recommended by authorities including WHO, but nothing has actually been finalized till date. The present study was planned to evaluate the effectiveness of an Ayurvedic formulation viz. Arogya Kashayam-20 in the hospitalized cases of Covid-19.Aim: To evaluate the effectiveness of Arogya Kashayam-20 in the cases of COVID-19 particularly the negative conversion of RTPCR in 10 days duration.Material and Methods: This was a randomized controlled trial conducted at COVID-19 Care Center, Pt. Khushilal Sharma Government Ayurveda College & Institute, Bhopal, Madhya Pradesh with a sample size of 112 participants, aged between 16 to 60 years of either sex. Participants were divided in two groups viz. group A and B. Both the groups received Hydroxychloroquine (HCQ), vitamin C and Zinc as per the prevailing ICMR guidelines and group 'A' received additionally Arogya Kashayam-20 for 10 days. Outcome measure of the study was to see the negative conversion RT-PCR test after intervention period of 10 days. CTRI Registration: CTRI/2020/06/026221. Results: Among the 60 cases registered in study group (group A), 51 cases (85.00%) were reported with negative RTPCR on 10th day. Out of 52 cases registered in control group (group B); 39 cases (75.00%) were tested negative RTPCR on 10th day. In both the groups all the cases were discharged asymptomatically on 10th day as per the prevailing ICMR guidelines. No ADR/AE observed during the intervention period.Conclusion: The study observes that the add on intervention group has a better outcome in terms of RT-PCR negative reports after 10 days comparing to the control group.

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No evidence of effectiveness of mirror therapy early after stroke: an assessor-blinded randomized controlled trial

Clinical Rehabilitation ◽

10.1177/0269215518824737 ◽

2019 ◽

Vol 33 (5) ◽

pp. 885-893 ◽

Cited By ~ 3

Author(s):

Paola Antoniotti ◽

Laura Veronelli ◽

Antonio Caronni ◽

Alessia Monti ◽

Evdoxia Aristidou ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Upper Limb ◽

Controlled Trial ◽

Intervention Group ◽

Functional Independence ◽

Control Group ◽

Mirror Therapy ◽

Randomized Controlled ◽

Significant Difference ◽

Flexion Extension

Objective: The aim of this study was to investigate the efficacy of mirror therapy on upper-limb recovery in early post-stroke patients. Design: Assessor-blinded randomized controlled trial. Setting: Inpatient rehabilitation clinic. Subjects: A total of 40 patients with upper-limb impairment due to a first-ever ischaemic or haemorrhagic stroke, within four weeks from the cerebrovascular accident. Intervention: The intervention group received mirror therapy, while the control group received sham therapy. During mirror therapy, patients’ sound hand was reflected by a mirror. During sham therapy, an opaque surface replaced the mirror-reflecting surface. Both the mirror therapy and sham therapy groups practised their sound hand with exercises, ranging from the simple elbow flexion–extension to complex tasks (e.g. reaching and grasping). Mirror therapy and sham therapy were added to conventional rehabilitation. Main measures: Primary outcome includes Fugl–Meyer upper extremity scale. Secondary outcomes include action research arm test (ARAT) and functional independence measure (FIM) scale. Outcomes were measured at the beginning (T0) and end (T1) of the treatment. Results: At baseline, both groups (sham therapy vs. mirror therapy; mean (SD)) were comparable for Fugl–Meyer (30.9 (23.9) vs. 28.5 (21.8)), ARAT (25.1 (25.5) vs. 23.5 (24)) and FIM (71.0 (20.6) vs. 72.9 (17.8)) scores. At the end of the treatment, both groups significantly improved in the Fugl–Meyer (40.6 (21.3) vs. 38.3 (23.4)), ARAT (31.9 (23.0) vs. 30 (24.1)) and FIM (100.3 (21.9) vs. 99.4 (22.6)) scores. However, at T1, no significant difference was observed between the sham therapy and mirror therapy groups, neither for the Fugl–Meyer, nor for ARAT and FIM scores. Conclusion: Compared with sham therapy, mirror therapy did not add additional benefit to upper-limb recovery early after stroke.

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Evaluation of the influence of Active Rehabilitation camps on the functional abilities in persons with tetraplegia

Advances in Rehabilitation ◽

10.2478/rehab-2013-0038 ◽

2012 ◽

Vol 26 (2) ◽

pp. 51-56

Author(s):

Lech Furmaniuk ◽

Grażyna Cywińska-Wasilewska

Keyword(s):

Preliminary Investigation ◽

Functional Independence Measure ◽

Functional Independence ◽

Mean Value ◽

Control Group ◽

Functional Abilities ◽

Motor Score ◽

Group A ◽

Active Rehabilitation ◽

Group B

Abstract Introduction: Every year, about 400 new patients with tetraplegia arise in Poland. The solution ensuring the continuation of the rehabilitation process of such patients is the activity of non-governmental organizations associating disabled people. Among them Foundation of Active Rehabilitation (FAR) has greatest experience in rehabilitation of people after SCI. Annually, about 70 persons with tetraplegia participate in Active Rehabilitation (AR) camps. Aim of this study was to estimate the influence of AR camps on the functional abilities in persons with tetraplegia. Material and methods: 40 men with tetraplegia were examined. Subjects were divided into two groups: participants of AR camps (group A, n=20) and control (group B, n=20). TheASIA motor score was used to estimate the degree of upper limb impairment. Functional Independence Measure (FIM)was used to assess functional abilities. All subjects were assessed in the beginning of the study and reassessed after 8 days. Results: Both groups during preliminary investigation were homogeneous under regard the ASIA motor score as well as the results of FIM. During final investigations significant improvement of FIM was noted only in group A. The mean value of FIM significantly increased about 10.8 points. In group A significant correlation between FIM scores and ASIA motor score were found (p<0.001). Conclusion: Improvement of functional skills among patients with tetraplegia which participated in AR camps was observed. The highest improvement in FIM was observed among persons with a C6 tetraplegia. Obtained results (ceiling effect) through of examined persons from C7 tetraplegia were suggested the need of applying more sensitive tests.

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Effects of a Health Education program on cognition, mood and functional capacity

Revista Brasileira de Enfermagem ◽

10.1590/0034-7167-2016-0638 ◽

2017 ◽

Vol 70 (4) ◽

pp. 814-821 ◽

Cited By ~ 1

Author(s):

Juliane Cristine Dias ◽

Isabela Azevedo Rodrigues ◽

Francine Golghetto Casemiro ◽

Diana Quirino Monteiro ◽

Bruna Moretti Luchesi ◽

...

Keyword(s):

Health Education ◽

Group Dynamics ◽

Functional Capacity ◽

Intervention Program ◽

Intervention Group ◽

Functional Independence Measure ◽

Functional Independence ◽

Cognitive Stimulation ◽

Control Group ◽

Controlled Clinical Trial

ABSTRACT Objective: Assess the effect of a Health Education (HE) program on cognition, mood and functional capacity of participants in a University of The Third Age (U3A). Method: Controlled clinical trial. The HE Program consisted of 10 sessions with group dynamics, including orientations on disease prevention and cognitive stimulation exercises, lasting four months. Intervention Group (IG) n=13; and Control Group (CG) n=15. All were assessed at the start and end of the study, using Addenbrook´s Cognitive Examination-Revised (ACE-R), Beck Depression and Anxiety Inventory (BDI/BAI) and Functional Independence Measure (FIM). Results: Significant improvements were observed for the IG when comparing the total ACE-R score (p=0.001) and memory domain (p=0.011) before and after the intervention. For the CG, improvement was found in the memory domain only (p=0.027). Conclusion: a HE intervention program benefits the improvement in cognitive performance, particularly the memory of adults and active elderly who participated in a U3A.

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Can rehabilitation improve the health and well-being in Friedreich’s ataxia: a randomized controlled trial?

Clinical Rehabilitation ◽

10.1177/0269215517736903 ◽

2017 ◽

Vol 32 (5) ◽

pp. 630-643 ◽

Cited By ~ 4

Author(s):

Sarah C Milne ◽

Louise A Corben ◽

Melissa Roberts ◽

Anna Murphy ◽

Geneieve Tai ◽

...

Keyword(s):

Friedreich Ataxia ◽

Intervention Group ◽

Functional Independence Measure ◽

Well Being ◽

Functional Independence ◽

Friedreich’S Ataxia ◽

Friedreich's Ataxia ◽

Home Exercise ◽

Control Group ◽

Health And Well Being

Objective: To determine the effectiveness of a six-week rehabilitation programme followed by a home exercise programme for Friedreich’s ataxia. Design: Randomized, delayed-start control single-blind trial. Setting: Outpatient rehabilitation centre. Subjects: Ambulant or non-ambulant individuals with Friedreich’s ataxia. Intervention: Participants were randomized to a six-week outpatient rehabilitation programme, immediately (intervention group) or after a six-week delayed-start (control group). The rehabilitation was followed by a six-week home exercise programme. Main measures: The primary outcome was the Functional Independence Measure. Other measures included the Friedreich Ataxia Impact Scale and the Friedreich Ataxia Rating Scale. Outcomes were administered at baseline, 6, 12 and 18 weeks. Results: Of 159 individuals screened, 92 were excluded and 48 declined to participate. A total of 19 participants were enrolled in the study. There was no significant difference in Functional Independence Measure change from baseline to six weeks in the intervention group (mean ± standard deviation, 2.00 ± 3.16) as compared to the control group (0.56 ± 4.06). Change in the Friedreich Ataxia Impact Scale body movement subscale indicated a significant improvement in health and well-being in the intervention group compared to the control group ( P = 0.003). Significant within-group improvements in the Friedreich Ataxia Impact Scale and the motor domain of the Functional Independence Measure post-rehabilitation were not sustained post-home exercise programme. Conclusion: Our study indicates that rehabilitation can improve health and well-being in individuals with Friedreich’s ataxia; however, a larger study is required to have sufficient power to detect a significant change in the most sensitive measure of function, the motor domain of the Functional Independence Measure.

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Mirror Visual Feedback Prior to Robot-Assisted Training Facilitates Rehabilitation After Stroke: A Randomized Controlled Study

Frontiers in Neurology ◽

10.3389/fneur.2021.683703 ◽

2021 ◽

Vol 12 ◽

Author(s):

Jifeng Rong ◽

Li Ding ◽

Li Xiong ◽

Wen Zhang ◽

Weining Wang ◽

...

Keyword(s):

Grip Strength ◽

Visual Feedback ◽

Functional Independence Measure ◽

Functional Independence ◽

Controlled Study ◽

Control Group ◽

Robot Assisted ◽

Randomized Controlled ◽

Mirror Visual Feedback ◽

Experimental Group

Purpose: Robot-assisted training has been widely used in neurorehabilitation, but its effect on facilitating recovery after stroke remains controversial. One possible reason might be lacking consideration of the role of embodiment in robotic systems. Mirror visual feedback is an ideal method to approach embodiment. Thus, we hypothesized that mirror visual feedback priming with subsequent robot-assisted training might provide additional treatment benefits in rehabilitation.Method: This is a prospective, assessor-blinded, randomized, controlled study. Forty subacute stroke patients were randomly assigned into an experimental group (N = 20) or a control group (N = 20). They received either mirror visual feedback or sham-mirror visual feedback prior to robot-assisted training for 1.5 h/day, 5 days/week for 4 weeks. Before and after intervention, the Fugl-Meyer Assessment Upper Limb subscale, the Functional Independence Measure, the modified Barthel Index, and grip strength were measured. Scores of four specified games were recorded pre and post one-time mirror visual feedback priming before intervention in the experimental group.Results: All measurements improved significantly in both groups following interventions. Moreover, the Fugl-Meyer Assessment Upper Limb subscale, self-care subscale of the Functional Independence Measure, and the grip strength were improved significantly in the experimental group after a 4-week intervention, compared with the control group. Significantly higher scores of two games were revealed after one-time priming.Conclusions: Mirror visual feedback prior to robot-assisted training could prompt motor recovery, increase ability of self-care, and potentially enhance grip strength in stroke patients, compared to control treatment. Moreover, mirror visual feedback priming might have the capability to improve the patient's performance and engagement during robot-assisted training, which could prompt the design and development of robotic systems.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: ChiCTR1900023356.

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Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

10.2196/preprints.12950 ◽

2018 ◽

Author(s):

Musheer Abdulwahid Al-Jaberi ◽

Muhamad Hanafiah Juni ◽

Hayati Kadir Shahar ◽

Siti Irma Fadhilah Ismail ◽

Murad Abdu Saeed ◽

...

Keyword(s):

International Students ◽

Acculturative Stress ◽

Educational Program ◽

Public Universities ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Policy Makers ◽

Randomized Controlled ◽

Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i><.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;EncHid=&amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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Effectiveness of a web-based medication adherence tool with patient centered communication: Results of a clustered randomized controlled trial (Preprint)

10.2196/preprints.16141 ◽

2019 ◽

Author(s):

Jan van Lieshout ◽

Joyca Lacroix ◽

Aart van Halteren ◽

Martina Teichert

Keyword(s):

Randomized Controlled Trial ◽

Medication Adherence ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Community Pharmacies ◽

Web Based ◽

Randomized Controlled ◽

Tailored Interventions ◽

Increased Risk

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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