The Effects of Body Weight Supported Treadmill Training On Static And Dynamic Balance In Stroke Patients: A Randomized-Single Blind Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul University
- Enrollment
- 45
- Locations
- 2
- Primary Endpoint
- Berg Balance Scale (BBS)
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
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.
Intervention: Body Weight Supported Treadmill Training (Other)
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.
Outcomes
Primary Outcomes
Berg Balance Scale (BBS)
Time Frame: 6 weeks
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.
Timed Up and Go Test (TUG)
Time Frame: 6 weeks
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.
Single Leg Stance Test (SLST)
Time Frame: 6 weeks
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.
The Falls Efficacy Scale-International (FES-I)
Time Frame: 6 weeks
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.
Secondary Outcomes
- The Comfortable and the Fast Gait Speed tests (CGS and FGS)(6 weeks)
- The Stair Climbing ascend and descend tests (SCas and SCde)(6 weeks)
- Rivermead Mobility Index (RMI)(6 weeks)
Investigators
RUSTEM MUSTAFAOGLU
MSc, PT
Istanbul University