Does Isolated Robotic-Assisted Gait Training Improve Functional Status, Daily Living And Quality Of Life In Stroke?

Study Overview
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Brief Summary
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Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen. Although most of the stroke survivors experience some level of neurological recovery, nearly 50%-60% of stroke patients still experience some degree of motor impairment, and approximately 50% are at least partly dependent in activities-of-daily-living (ADL). Gait recovery, performing activities of daily living and regaining independence in ADLs are the main focus of stroke rehabilitation programs. Robotic technologies are becoming more promising techniques for the locomotor training in stroke patients. Achieving a functional walking level is one of the target of robotic gait training and it has been shown that Robotic-Assisted Gait Training (RAGT) improves walking function in stroke patients. Having a functional gait level may help the stroke patients to regain independence in ADLs and improve quality of life. The purpose of the present study was to investigate the effects of RAGT on functional status, ADLs and health related quality of life.

Detailed Description
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Design: Our study design was a randomized single-blind controlled study of 6 weeks including inpatient ambulatory subacute and chronic stroke patients. Sample size was calculated by Raosoft, Inc. Clinically meaningful difference was considered 20% for all outcome measures. The original sample size was estimated 45 patients to detect a statistically significant difference between groups. Considering the drop-out, fifty-one patient were included. The patients were randomly assigned to one of three training group by a researcher (ARO) using the function of Microsoft Office Excel software. In this randomized-controlled study, eighty patients were assessed in terms of eligibility criteria, and 51 patients were included in the study. The patients were evaluated by two physiatrists in Istanbul Physical Medicine and Rehabilitation Education and Research Hospital and referred to the Physiotherapy and Rehabilitation Unit of the same hospital. Enrollment period was between November 2014 and December 2015. Blinding: During the consent process, participants were advised that they would be randomized to one of three intervention groups. To minimize exposure between groups, the Robot-Assisted Gait Training and Conventional Training programs were administered in different sections of the rehabilitation center. The 2 trial physiotherapists could blinded to intervention group. All treatment schedules were planned by another researcher. All outcome assessments were conducted by a blinded assessor located offsite. Trial staff instructed participants to avoid mentioning anything about their intervention to the assessor. Patients were asked not to shear any information about treatment between each other.

Official Title
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Does Isolated Robotic-Assisted Gait Training Improve Functional Status, Daily Living And Quality Of Life In Stroke Patients?: A Single-Blinded Randomized Controlled Study

Conditions
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Cerebrovascular Stroke, Cerebrovascular Accident, Cerebral Stroke

Intervention / Treatment
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* Other: Robotic-Assisted Gait Training


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: diagnosis of a stroke (at least 3 months), ambulatory with or without the use of an assistive device or ankle-foot orthosis, 3 or higher grades in Functional Ambulation Category, able to walk 10 meters with or without supervision, able to follow verbal instructions, physician approval to enter an exercise program. Exclusion criteria: previous stroke history, any other neurologic disorders, complications from other health conditions (cardiovascular or musculoskeletal conditions), contracture or muscle tonus ≥ 3 according to Modified Ashworth Scale, preventing range of motion in lower extremity, severe osteoporosis, cognitive deficit preventing them from following instructions.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 physical therapy consisted of neurophysiological concepts such as Bobath and Brunnstrom.Training sessions focused on static and dynamic postural tasks, improving lower and upper extremity range of motion, strengthening and overground walking. During walking training, emphasis was on distance walked than on gait quality. Symmetrical weight distribution was encouraged through verbal and tactile cues and was made more difficult by the addition of arm activities or actions requiring trunk rotation. In an effort to improve rhythmic weight-shifting ability, subjects practiced shifting their weight in forward and backward directions and side to side while performing reaching tasks. A session lasted 45 minutes, for 5 days per week for 6 weeks. | |
| Experimental: Robotic-Assisted Gait Training<br>Lokomat (Hocoma) was used in Robotic-Assisted Gait Training 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. Robotic-Assisted Gait Training sessions lasted 45-minute sessions, 2 days a week during 6 weeks. | Other: Robotic-Assisted Gait Training<br>* There were three intervention arms in this study, Robotic-Assisted Gait Training, Conventional Training, 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-Robotic-Assisted Gait Training, 2 days a week during 6 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Barthel Index (BI) | The BI was used to determine the level of independence in functional activities and included ten items. The score ranges from 0-100, and a higher BI score indicates better functioning. Minimal clinically important difference for BI is 18.5 points. | 6 weeks | 
| The Stroke Specific Quality of Life Scale (SSQOL). | The Stroke Specific Quality of Life scale (SS-QOL) was used to address the ICF participation component.The score for the questionnaire is between 26 (lowest social participation) and 130 (highest social participation). | 6 weeks | 
| The 6-Minute Walk Test (6MWT) | Walking function was assessed by distance walked in 6 minutes (6MWT).Usual ambulatory devices, lower-extremity orthotics, and stand-by assistance were permitted. Therapists closely guarded participants during gait testing, but did not provide physical assistance. For the 6-minute walk test, participants walked through continuous hallways with minimal foot traffic. End of the test walked distance recorded by meter. | 6 weeks | 
| The Stair Climbing ascend and descend tests (SCas and SCde) | Participants climbed up and down 10 steps (measuring 18 cm in height), with or without the use of the rails and/or assistive devices. Subjects were asked to climb the stairs without skipping any steps, preferably using one foot for each step and descend without stopping. The time taken to climb up and down the 10 steps was recorded as a second. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Fugl-Meyer Assessment (FMA) | Lower limb impairment and balance were measured by Fugl-Meyer Lower Extremity Assessment (FMA-LE).FMA-LE consists of 17 items, with a maximum possible score of 34 points. Each item was answered using a 3-point ordinal scale (0 = cannot perform, 1 = can partially perform, 2 = can fully perform). | 6 weeks | 
| The Comfortable 10-m Walk Test (CWT) | CWT was used to determine the speed of comfortable walking. The test was applied in a 14 meter-corridor. 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. After three trials the average of the three trials was recorded as a second. | 6 weeks | 
| Rate of Perceived Exertion (RPE) | Rate of Perceived Exertion was assessed at the end of 6 MWT and the patients were asked to identify their level of exertion between 6-20.All measurements of were performed before the intervention (baseline) and after the intervention (post treatment). | 6 weeks | 
| The Fast 10-m Walk Test (FWT) | FWT was used to determine the speed of fast walking. The test was applied in a 14 meter-corridor. The patients were wanted to walk fast and allowed to use walking aid. At 2nd meter the stopwatch was started and stopped when the patient reached the 12th meter. After three trials the average of the three trials was recorded as a second. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Gait, Ambulation, Exercise Therapy, Physical Exertion, Motor Skills