Clinical trial NCT02735148: The Effects of Body Weight Supported Treadmill Training On Balance In Stroke Patients
Official title: The Effects of Body Weight Supported Treadmill Training On Static And Dynamic Balance In Stroke Patients: A Randomized-Single Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Stroke
Cerebral Stroke
Cerebrovascular Accident
Keywords: Postural balance
Accidental falls
Rehabilitation
Cerebrovascular Accident
Walking
Mobility limitation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is one of the most common causes of acquired adult disability. The majority of stroke survivors have mobility difficulties such as poor standing, decreased walking speed, balance disturbances, and increased risk for falls. Improving mobility, functional walking and balance are the main goals of stroke rehabilitation. Robotic technologies are becoming more promising intervention for the locomotor training in stroke rehabilitation. Static or dynamic balance deficits act crucial role on gait performance among stroke survivors. Therefore it is important to determine the effects of BWSTT in improving balance in persons with stroke. Although it has been demonstrated that BWSTT improved balance and gait performance in stroke patients, it is not clear whether the improvements are greater compared with those associated with other gait rehabilitation methods. To the investigators knowledge, there are also limited studies in the literature concerning the effects of BWSTT on falling risk in stroke patients. The strong evidence is needed about the effectiveness of BWSTT including comprehensive determinants of balance with combined and isolated intervention groups.This study aims to compare the effects of BWSTT with combined and isolated intervention on balance, gait and fall risk in patients with subacute and chronic stroke. The investigators hypotheses are that after stroke:

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.

Detailed description: Participants:

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.

Eligibility criteria: Inclusion Criteria:

* stroke onset at least 3 months before the study
* 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:

* previously having stroke
* 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

Primary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 6 weeks
measure: Single Leg Stance Test (SLST)
timeFrame: 6 weeks
measure: Timed Up and Go Test (TUG)
timeFrame: 6 weeks
measure: The Falls Efficacy Scale-International (FES-I)
timeFrame: 6 weeks
Secondary outcomes:
measure: Rivermead Mobility Index (RMI)
timeFrame: 6 weeks
measure: The Comfortable and the Fast Gait Speed tests (CGS and FGS)
timeFrame: 6 weeks
measure: The Stair Climbing ascend and descend tests (SCas and SCde)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Training Hospital
city: Istanbul
country: Turkey
facility: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
Study officials:
affiliation: Istanbul University, Faculty of Health Science, Division of Physiotherapy and Rehabilitation
name: IPEK YELDAN, Assoc.prof
role: STUDY_DIRECTOR
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