THE EFFECT OF CAREGIVER EDUCATION PROGRAM ON FUNCTIONAL INDEPENDENCE AND MORTALITY IN FIRST-EVER STROKE

Background: At present, the management of stroke focuses not only on the acute stage of saving the penumbra but also on the secondary prevention of managing the potential sequel following stroke, preventing the occurrence of another attack, and improving the quality of life. Continuous role of caregivers in supporting stroke survivor after passing the acute phase is therefore invaluable. Caregiver education program (CEP) was routinely used as a part of discharge plan on acute stroke patients in stroke unit in Indonesia. This study aims to evaluate the effect of CEP as one of stroke rehabilitation modalities using a historical data that still correlated to the practice in stroke unit nowadays. Methods: A single-blinded randomized controlled trial was performed on 172 subjects of first-ever stroke with no other comorbidities and not having invasive treatment on the recruitment time. The subjects were randomly allocated into two groups: a group receiving CEP (n=88) as the experiment group and a control group (n=84). A four-session CEP, held since the second week of admission by interactive discussion using overhead projector and poster, was performed by a neurologist to the caregiver member of experiment group stroke survivor. The outcome of functional independence and mortality on the third month post-onset was assessed using Barthel activity daily living (ADL) index and the mortality report, respectively. Results: No statistical difference was found on the baseline of the two groups. CEP significantly increased the functional independence (RR=1.30, 95% CI 1.03-1.63) of stroke survivor. Despite the insignificant effect on three-month survival, the group receiving CEP had less mortality rate over time. Conclusion: Caregiver education program had a positive outcome on the patient’s functional independence. Thus, it improves the quality of life.

Download Full-text

Randomised controlled trial of the effects of a self-management patient education program on overall quality of life and knee pain of older people with mild to moderate knee(s) osteoarthritis

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20171918 ◽

2017 ◽

Vol 4 (2) ◽

pp. 80

Author(s):

Alhadi M. Jahan

Keyword(s):

Quality Of Life ◽

Patient Education ◽

Education Program ◽

Repeated Measures ◽

Controlled Trial ◽

Self Management ◽

Controlled Study ◽

Control Group ◽

Human Beings

Background: Knee osteoarthritis (OA) is the most important chronic rheumatic disease affecting human beings. It is more common among the older population. The objective of OA treatment is to control the symptoms, such as pain, mobility problems and consequently, to improve overall quality of life. Although, self-management patient education programs, such as educational workshops and other learning activities are effective approaches in some chronic diseases, the evidence for arthritis is still inconclusive. The aim of this trial is to compare the effectiveness of an OA of the knee self-management education program with a control group, as determined by improvements in pain and quality of life. Methods: In this study, we will perform a two-group, randomized (1:1 ratio), controlled study with repeated-measures to examine the differences between the two groups over time. The research sample will be selected from the patients who are referred to a physiotherapy department with a diagnosed mild to moderate knee(s) OA, aging from 45 to 65 years.Conclusions: Positive findings of this trial will pave the road for new methods of cooperation between patients and healthcare providers. Also, patient education ensures that patients are well-informed about their own health and they could avoid any deterioration and disability due to bad practices. Finally, an increased understanding helps patients to make informed decisions about their healthcare avenues.

Download Full-text

Effects of exergames training on postural balance in patients who had a chronic stroke: study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-038593 ◽

2020 ◽

Vol 10 (11) ◽

pp. e038593

Author(s):

Nathalia Priscilla Oliveira Silva Bessa ◽

Bartolomeu Fagundes de Lima Filho ◽

Candice Simões Pimenta de Medeiros ◽

Tatiana Souza Ribeiro ◽

Tânia Fernandes Campos ◽

...

Keyword(s):

Quality Of Life ◽

Postural Balance ◽

Controlled Trial ◽

Functional Independence ◽

Chronic Stroke ◽

Cortical Activation ◽

Control Group ◽

Quality Of Life Scale ◽

Functional Reach Test

IntroductionExergames training, as an additional therapy to standard care, has been widely used for motor recovery after patients who had a stroke, and it is a valuable and positive tool in the rehabilitation of this population. This study describes a single-blind randomised clinical trial that will aim to investigate the effects of exergames training on postural balance in patients with chronic stroke.Methods and analysisForty-two individuals with chronic stroke (>6 months), aged 20–75 years, will be randomised into two groups: the experimental group, which will be subjected to an exergames protocol, and control group, which will undergo a kinesiotherapy protocol. Both protocols are based on postural balance. The intervention will consist of 40-minute sessions two times per week for 10 consecutive weeks. The volunteers will be evaluated before the treatment, at the end of the interventions and 8 weeks thereafter. The primary outcome will be postural balance (Berg Balance Scale, Functional Reach Test, Timed Up and Go test and Centre of Pressure variables) and secondary outcomes will include gait (6 m timed walk and Kinovea Software), cortical activation patterns (electroencephalography Emotiv EPOC), functional independence (Functional Independence Measure), quality of life (Stroke-Specific Quality of Life Scale) and motivation (Intrinsic Motivation Inventory).Ethics and disseminationThis protocol was approved by the Ethics Committee of the Federal University of Rio Grande do Norte (number 3.434.350). The results of the study will be disseminated to participants through social networks and will be submitted to a peer-reviewed journal and scientific meetings.Trial registration numberBrazilian Registry of Clinical Trials (RBR-78v9hx).

Download Full-text

Efficacy of pediatric integrative manual therapy in positional plagiocephaly: a randomized controlled trial

Italian Journal of Pediatrics ◽

10.1186/s13052-021-01079-4 ◽

2021 ◽

Vol 47 (1) ◽

Author(s):

Iñaki Pastor-Pons ◽

María Orosia Lucha-López ◽

Marta Barrau-Lalmolda ◽

Iñaki Rodes-Pastor ◽

Ángel Luis Rodríguez-Fernández ◽

...

Keyword(s):

Manual Therapy ◽

Education Program ◽

Controlled Trial ◽

Asymmetry Index ◽

Trial Registration ◽

Control Group ◽

Parental Perception ◽

Positional Plagiocephaly ◽

Caregiver Education ◽

Registration Number

Abstract Background Positional plagiocephaly frequently affects healthy babies. It is hypothesized that manual therapy tailored to pediatrics is more effective in improving plagiocephalic cranial asymmetry than just repositioning and sensory and motor stimulation. Methods Thirty-four neurologically healthy subjects aged less than 28 weeks old with a difference of at least 5 mm between cranial diagonal diameters were randomly distributed into 2 groups. For 10 weeks, the pediatric integrative manual therapy (PIMT) group received manual therapy plus a caregiver education program, while the controls received the same education program exclusively. Cranial shape was evaluated using anthropometry; cranial index (CI) and cranial vault asymmetry index (CVAI) were calculated. Parental perception of change was assessed using a visual analogue scale (− 10 cm to + 10 cm). Results CVAI presented a greater decrease in PIMT group: 3.72 ± 1.40% compared with 0.34 ± 1.72% in the control group (p = 0.000). CI did not present significant differences between groups. Manual therapy led to a more positive parental perception of cranial changes (manual therapy: 6.66 ± 2.07 cm; control: 4.25 ± 2.31 cm; p = 0.004). Conclusion Manual therapy plus a caregiver education program improved CVAI and led to parental satisfaction more effectively than solely a caregiver education program. Trial registration Trial registration number: NCT03659032; registration date: September 1, 2018. Retrospectively registered.

Download Full-text

Long-term effectiveness of telephone-based health coaching for heart failure patients: A post-only randomised controlled trial

Journal of Telemedicine and Telecare ◽

10.1177/1357633x16668436 ◽

2016 ◽

Vol 23 (8) ◽

pp. 716-724 ◽

Cited By ~ 11

Author(s):

Michel Tiede ◽

Sarah Dwinger ◽

Lutz Herbarth ◽

Martin Härter ◽

Jörg Dirmaier

Keyword(s):

Quality Of Life ◽

Heart Failure ◽

Locus Of Control ◽

Controlled Trial ◽

Health Coaching ◽

Analysis Of Covariance ◽

Control Group ◽

Heart Failure Patients ◽

Health Related

Introduction The * Equal contributors. health-status of heart failure patients can be improved to some extent by disease self-management. One method of developing such skills is telephone-based health coaching. However, the effects of telephone-based health coaching remain inconclusive. The aim of this study was to evaluate the effects of telephone-based health coaching for people with heart failure. Methods A total sample of 7186 patients with various chronic diseases was randomly assigned to either the coaching or the control group. Then 184 patients with heart failure were selected by International Classification of Diseases (ICD)-10 code for subgroup analysis. Data were collected at 24 and 48 months after the beginning of the coaching. The primary outcome was change in quality of life. Secondary outcomes were changes in depression and anxiety, health-related control beliefs, control preference, health risk behaviour and health-related behaviours. Statistical analyses included a per-protocol evaluation, employing analysis of variance and analysis of covariance (ANCOVA) as well as Mann-Whitney U tests. Results Participants’ average age was 73 years (standard deviation (SD) = 9) and the majority were women (52.8%). In ANCOVA analyses there were no significant differences between groups for the change in quality of life (QoL). However, the coaching group reported a significantly higher level of physical activity ( p = 0.03), lower intake of non-prescribed drugs ( p = 0.04) and lower levels of stress ( p = 0.02) than the control group. Mann-Whitney U tests showed a different external locus of control ( p = 0.014), and higher reduction in unhealthy nutrition ( p = 0.019), physical inactivity ( p = 0.004) and stress ( p = 0.028). Discussion Our results suggest that telephone-based health coaching has no effect on QoL, anxiety and depression of heart failure patients, but helps in improving certain risk behaviours and changes the locus of control to be more externalised.

Download Full-text

A Randomized Controlled Trial of Two Semi-Occluded Vocal Tract Voice Therapy Protocols

Journal of Speech Language and Hearing Research ◽

10.1044/2015_jslhr-s-13-0231 ◽

2015 ◽

Vol 58 (3) ◽

pp. 535-549 ◽

Cited By ~ 55

Author(s):

Mara R. Kapsner-Smith ◽

Eric J. Hunter ◽

Kimberly Kirkham ◽

Karin Cox ◽

Ingo R. Titze

Keyword(s):

Quality Of Life ◽

Vocal Tract ◽

Controlled Trial ◽

Voice Quality ◽

Voice Handicap Index ◽

Voice Therapy ◽

Control Group ◽

Perceptual Evaluation ◽

Therapy Program

PurposeAlthough there is a long history of use of semi-occluded vocal tract gestures in voice therapy, including phonation through thin tubes or straws, the efficacy of phonation through tubes has not been established. This study compares results from a therapy program on the basis of phonation through a flow-resistant tube (FRT) with Vocal Function Exercises (VFE), an established set of exercises that utilize oral semi-occlusions.MethodTwenty subjects (16 women, 4 men) with dysphonia and/or vocal fatigue were randomly assigned to 1 of 4 treatment conditions: (a) immediate FRT therapy, (b) immediate VFE therapy, (c) delayed FRT therapy, or (d) delayed VFE therapy. Subjects receiving delayed therapy served as a no-treatment control group.ResultsVoice Handicap Index (Jacobson et al., 1997) scores showed significant improvement for both treatment groups relative to the no-treatment group. Comparison of the effect sizes suggests FRT therapy is noninferior to VFE in terms of reduction in Voice Handicap Index scores. Significant reductions in Roughness on the Consensus Auditory-Perceptual Evaluation of Voice (Kempster, Gerratt, Verdolini Abbott, Barkmeier-Kraemer, & Hillman, 2009) were found for the FRT subjects, with no other significant voice quality findings.ConclusionsVFE and FRT therapy may improve voice quality of life in some individuals with dysphonia. FRT therapy was noninferior to VFE in improving voice quality of life in this study.

Download Full-text

Asthma in Adolescents: A Randomized, Controlled Trial of an Asthma Program for Adolescents and Young Adults with Severe Asthma

Canadian Respiratory Journal ◽

10.1155/2002/106262 ◽

2002 ◽

Vol 9 (4) ◽

pp. 253-259 ◽

Cited By ~ 21

Author(s):

Robert L Cowie ◽

Margot F Underwood ◽

Cinde B Little ◽

Ian Mitchell ◽

Sheldon Spier ◽

...

Keyword(s):

Quality Of Life ◽

Emergency Department ◽

Randomized Controlled Trial ◽

Asthma Control ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Randomized Controlled ◽

Disease Specific

BACKGROUND: Asthma is common and is often poorly controlled in adolescent subjects.OBJECTIVE: To determine the impact of an age-specific asthma program on asthma control, particularly on exacerbations of asthma requiring emergency department treatment, and on the quality of life of adolescents with asthma.METHODS: The present randomized, controlled trial included patients who were 15 to 20 years of age and had visited emergency departments for management of their asthma. The interventional group attended an age-specific asthma program that included assessment, education and management by a team of asthma educators, respiratory therapists and respiratory physicians. In the control group, spirometry was performed, and the patients continued to receive usual care from their regular physicians. The outcomes were assessed by a questionnaire six months after entry into the study.RESULTS: Ninety-three subjects entered the study and were randomly assigned to the intervention or control group. Of these, only 62 patients were available for review after six months. Subjects in both the control and the intervention groups showed a marked improvement in their level of asthma control, reflected primarily by a 73% reduction in the rate of emergency department attendance for asthma. Other indexes of disease control, including disease-specific quality of life, as assessed by questionnaires, were improved. There was, however, no discernible difference between the subjects in the two groups, with the exception of an improvement in favour of the intervention group in the symptom (actual difference 0.7, P=0.048) and emotional (actual difference 0.8, P=0.028) domains of the asthma quality of life questionnaire. The overall quality of life score favoured the intervention group by a clinically relevant difference of 0.6, but this difference did not reach statistical significance (P=0.06).CONCLUSIONS: Although all subjects demonstrated a significant improvement in asthma control and quality of life, the improvement attributable to this intervention was limited to two domains in disease-specific quality of life.

Download Full-text

Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

10.2196/preprints.29640 ◽

2021 ◽

Author(s):

Florie FILLOL ◽

Ludivine PARIS ◽

Sébastien PASCAL ◽

Aurélien MULLIEZ ◽

Christian-François ROQUES ◽

...

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Waist Circumference ◽

Controlled Trial ◽

Intervention Group ◽

Group Versus ◽

Control Group ◽

Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

Download Full-text

Hysteroscopic management of a uterine caesarean scar defect (niche) in women with postmenstrual spotting: a randomised controlled trial

QJM ◽

10.1093/qjmed/hcab115.005 ◽

2021 ◽

Vol 114 (Supplement_1) ◽

Author(s):

Hatem Hussein El-Gamal ◽

Walid El-Basuony Mohammad ◽

Ahmed Samir Mohamed Zeerban

Keyword(s):

Quality Of Life ◽

Caesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Expectant Management ◽

Control Group ◽

Randomised Controlled ◽

Caesarean Scar Defect ◽

Interventional Group

Abstract Background Long-term complaints after caesarean section, such as postmenstrual spotting, dysmenorrhea, dyspareunia, or chronic pelvic pain, are frequently described in relation to the presence of a niche. A post-caesarean niche is defined as an indentation in the myometrium at the site of the uterine scar. Two independent prospective cohort studies reported that the presence of a niche after caesarean section increases the risk of postmenstrual spotting for more than 2 days from 15 to 30%. Postmenstrual spotting may be caused by a mechanical outflow problem, with the retention of menstrual blood in a niche, or by the accumulation of blood because of impaired uterine contractions at the site of the niche. Additionally, newly formed fragile vessels in the niche may play a role in the formation of blood or fluid in the niche and uterine cavity. Objective The aim of this study was to compare the effectiveness of a hysteroscopic niche resection versus no treatment in women with postmenstrual spotting and a uterine caesarean scar defect. Methods This trial is a randomised controlled trial that provides evidence for the (cost) effectiveness of hysteroscopic resection of a niche versus expectant management in women with niche related postmenstrual spotting. It was carried out on 28 cases divided into two equal group. The study was conducted at Ain Shams University on the women reporting postmenstrual spotting after a caesarean section. The primary outcome was the number of days of postmenstrual spotting 6 months after randomization. Secondary outcomes were spotting at the end of menstruation, intermenstrual spotting, dysuria, sonographic niche measurements, quality of life, women’s satisfaction, sexual function, and additional therapy. Outcomes were measured at 3 months and, also at 6 months after randomization. Results The results of this study show a significant improvement in interventional group after 3 months more than the control group in bleeding micturition characteristics which includes total days of spotting, spotting end of menstruation, intermenstral spotting, discomfort from spotting, dysmenorrhea and daily pain during micturition, after 6 months the two group improved but the interventional group was significantly higher than control group. Regarding the radiological assessment it was found that there was a significant improvement in intervention group more than the control group after 3 months, also the control group improved after 6 months also, but the intervention groups was significantly higher than the control group. The quality of life show a significant increasing in intervention group more than the control group after 3 months of intervention, at the end of follow up the intervention group was significantly higher in quality of life more than the control group. Conclusion A hysteroscopic niche resection reduces postmenstrual spotting, and the discomfort from spotting, compared with expectant management after 3 months of follow-up in women with a niche with a residual myometrium of at least 3 mm.

Download Full-text

Comparison of kinesio taping and cold therapy in patients with total knee arthroplasty: A randomized controlled trial

Clinical Rehabilitation ◽

10.1177/02692155211049152 ◽

2021 ◽

pp. 026921552110491

Author(s):

Ertugrul Yuksel ◽

Bayram Unver ◽

Vasfi Karatosun

Keyword(s):

Quality Of Life ◽

Muscle Strength ◽

Range Of Motion ◽

Therapy Group ◽

Controlled Trial ◽

Control Group ◽

Functional Level ◽

Kinesio Taping ◽

Cold Therapy

Objective To investigate the effects of kinesio taping and cold therapy on pain, edema, range of motion, muscle strength, functional level and quality of life in patients with total knee arthroplasty. Design Randomised controlled trial. Setting A university hospital. Subjects One-hundred patients were included. Intervention Patients were allocated into three groups; control group, kinesio group and cold therapy group. The control group received a standard rehabilitation program. Kinesio taping group received two fan-shaped kinesio taping bands and cold therapy group received cold packs in addition to the standard rehabilitation program. Main measures The outcome measures were pain, edema, range of motion, muscle strength, functional level and quality of life. Participants were assessed at preoperative, discharge and postoperative third month. Results The groups were similar at preoperative. A significant difference was determined in terms of pain in kinesio taping group compared to the control group at the discharge. Cold therapy was efficient in reducing postoperative swelling but kinesio taping had no significant effects on swelling control. There was no difference between the groups in terms of range of motion, muscle strength, functional level and quality of life. The groups were similar in all parameters at the postoperative third month measurements. Conclusion Fan-shaped kinesio taping is an effective technique in terms of postoperative pain relief. Cold therapy is an effective method in terms of edema control. Kinesio taping and cold therapy has no specific beneficial effect on functional level, muscle strength and quality of life compared to control group.

Download Full-text

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽

10.1093/neuros/nyx363 ◽

2017 ◽

Vol 83 (1) ◽

pp. 146-153 ◽

Cited By ~ 2

Author(s):

Pierre-Yves Borius ◽

Stéphanie Ranque Garnier ◽

Karine Baumstarck ◽

Frédéric Castinetti ◽

Anne Donnet ◽

...

Keyword(s):

Quality Of Life ◽

Pain Relief ◽

Cancer Pain ◽

Controlled Trial ◽

Analgesic Efficacy ◽

Standards Of Care ◽

Control Group ◽

Efficacy And Safety ◽

Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

Download Full-text