The Effects of Body Weight Supported Treadmill Training On Balance In Stroke Patients

Study Overview
=================
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: the combination of BWSTT with conventional training may lead to more improved balance parameters; 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.

Official Title
-----------------
The Effects of Body Weight Supported Treadmill Training On Static And Dynamic Balance In Stroke Patients: A Randomized-Single Blind Study

Conditions
-----------------
Cerebrovascular Stroke, Cerebral Stroke, Cerebrovascular Accident

Intervention / Treatment
-----------------
* Other: Body Weight Supported Treadmill Training


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Training<br>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. | |
| Experimental: Body Weight Supported Treadmill Training<br>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. | Other: Body Weight Supported Treadmill Training<br>* There were three intervention arms in this study, Body Weight Supported Treadmill Training, Conventional Training and Combined Training.<br>|
| No Intervention: Combined Training<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg Balance Scale (BBS) | This 14-item objective measure was used to assess postural control and balance of the participants. Item-level scores of BBS range from 0-4; summed score of the items were used in this study. Higher score indicates better mobility performance. | 6 weeks | 
| Single Leg Stance Test (SLST) | SLST was performed with eyes open while resting the arms on the hips. The participant stand on one leg with this position and timed in seconds from time one foot is flexed to time when s/he touched the ground, jumped or touched anything to support was calculated by the physiotherapist three times. After three trials the average of the three trials was recorded. Shortening the time to stand on one leg was a marker for decreased balance function. | 6 weeks | 
| Timed Up and Go Test (TUG) | TUG is a reliable and simple test to assess balance and functional mobility of stroke patients. The patient sited in chair and with command of physiotherapist raised from the chair, walked 3 meters, walked back to the chair and sited down again. The time of process was recorded by the physiotherapist in seconds. It was allowed to use walking aid during the test. Lower duration indicates better mobility performance. | 6 weeks | 
| The Falls Efficacy Scale-International (FES-I) | FES-I was used to assessed the anxiety level of participants about falling while performing activities indoor or outdoor. It has 16 items scored on a 4-point Likert scale. We used Turkish version of FES-I in our study. Higher score indicates better mobility performance. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rivermead Mobility Index (RMI) | RMI was used to assess functional mobility of the patients. In this 15-item test, the items about mobility progress in difficulty including rolling in bed to running. Items are coded as either 0 or 1 depending on whether the patient can complete the task. Total score are determined by summing the points. Higher score indicates better mobility performance. | 6 weeks | 
| The Comfortable and the Fast Gait Speed tests (CGS and FGS) | The Comfortable and the Fast Gait Speed tests (CGS and FGS)was used to determine the speed of walking. The test was applied in a corridor between two chairs which were placed 14 meters apart. 0, 2nd, 12th and 14th meters were determined. The patients were wanted to walk comfort and allowed to use walking aid. At 2nd meter the stopwatch was started and stopped when the patient reached the 12th meter. The time of process was recorded by the physiotherapist in seconds. Lower duration indicates better mobility performance. | 6 weeks | 
| The Stair Climbing ascend and descend tests (SCas and SCde) | Duration of ascending and descending 10 steps was measured in seconds with a stopwatch. Step height of the stair was 20 cm. The participants did not allowed to get support from latter bar. The time of process was recorded by the physiotherapist in seconds.After three trials the average of the three trials was recorded. Lower duration indicates better mobility performance. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postural balance, Accidental falls, Rehabilitation, Cerebrovascular Accident, Walking, Mobility limitation