The Effects of Body Weight Supported Treadmill Training On Balance In Stroke Patients
NCT ID: NCT02735148
Last Updated: 2017-03-03
Study Results
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Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2014-11-30
2015-11-30
Brief Summary
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1. the combination of BWSTT with conventional training may lead to more improved balance parameters;
2. when applied as an isolated intervention, BWSTT or conventional training may lead to similar results.
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Detailed Description
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All participants with stroke were recruited from a government rehabilitation hospital between November 2014 and November 2015. All treatments were performed in the same hospital.
Sample Size:
"Power and Sample Size Program" was used to calculate sample size. It was determined by considering a previous study which calculated minimal detectable change of Berg Balance Scale (BBS) for stroke patients(20). According to this study to the response within each subject group was normally distributed with standard deviation 7.87 and minimal detectable change was found 10% for BBS. It was calculated that 15 participants were needed in each group with probability (power) 0.8 and 0.016 alpha level computed by Bonferroni adjustment.
Procedure:
One hundred and seven stroke patient were assessed for eligibility by two physiatrists (B.E and B.G). Forty-two (13 women, range of age: 18-75 years) patients were found to be suitable for inclusion criteria of the study. Randomisation was performed by using randomisation function of Microsoft Office Excel programme by another researcher (ARO). Random number generator of Microsoft Office Excel Software gave a random number between 0 and 1 to the each treatment columns which were created by ARO. Sorting the random number row from the largest to the smallest number was performed by the sort and filter menu. Treatment assignments were stratified according to the severity of impairment at baseline and the study site to ensure balanced distribution among the three groups.After the randomisation,assessments at baseline and after training were performed by two physiotherapists who were blind to the interventions (IY, BEH). All the participants were treated in the rehabilitation hospital by a physiotherapist who was experienced in stroke rehabilitation. BWSTT Training was performed by RM.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional Training
Conventional training sessions generally consisted of exercises which aimed to improve range of motion, strength, and movement quality in upper and lower extremity as an in-patient rehabilitation protocol. Also developing static and dynamic postural control and increasing walking distance were the other aims of training. Duration of the Conventional Training is 45 minute per session, 3 days a week for 6 weeks.
No interventions assigned to this group
Body Weight Supported Treadmill Training
Body weight supported treadmill training (BWSTT) was composed of outpatients who were undertaken only BWST training with 45-minute sessions, 2 days a week during 6 weeks.
BWST Training
Locomat (Hocoma) was used in BWSTT group with 20 % body weight reduced. The participants walked on device at 1.8 km/h (0.5 m/sec) velocity. For each participant body weight portion was ensured by a security belt while walking. Each session took 45 minutes including setup, commands and rest time. Verbal instructions were used for encouragement but no manual assistance was given to improve gait pattern.
Body Weight Supported Treadmill Training
There were three intervention arms in this study,
1. Body Weight Supported Treadmill Training,
2. Conventional Training and
3. Combined Training.
Combined Training
Combined Training consisted of inpatient participants who were treated with 45 minute-conventional training, 5 days a week during 6 weeks. Additionally this group had 45 minute-BWST training, 2 days a week during 6 weeks.
No interventions assigned to this group
Interventions
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Body Weight Supported Treadmill Training
There were three intervention arms in this study,
1. Body Weight Supported Treadmill Training,
2. Conventional Training and
3. Combined Training.
Eligibility Criteria
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Inclusion Criteria
* being 18-75 years old
* to be able to walk 10 meter independently or under supervision
* to be able to walk independently with or without ankle-foot-orthosis
* to be able to understand all instructions during treatment sessions
Exclusion Criteria
* having other health conditions which prevent walking
* having contracture or range of motion limitation in lower extremity which affect walking
* having uncontrolled hypertension
* severe cognitive impairment
18 Years
75 Years
ALL
No
Sponsors
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Istanbul University
OTHER
Responsible Party
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RUSTEM MUSTAFAOGLU
MSc, PT
Principal Investigators
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IPEK YELDAN, Assoc.prof
Role: STUDY_DIRECTOR
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Locations
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Istanbul Physical Medicine and Rehabilitation Training Hospital
Istanbul, , Turkey (Türkiye)
Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Istanbul, , Turkey (Türkiye)
Countries
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References
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Other Identifiers
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A-23
Identifier Type: -
Identifier Source: org_study_id
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