Clinical trial NCT02759627: Does Isolated Robotic-Assisted Gait Training Improve Functional Status, Daily Living And Quality Of Life In Stroke?
Official title: Does Isolated Robotic-Assisted Gait Training Improve Functional Status, Daily Living And Quality Of Life In Stroke Patients?: A Single-Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Stroke
Cerebrovascular Accident
Cerebral Stroke
Keywords: Rehabilitation
Gait
Ambulation
Exercise Therapy
Physical Exertion
Motor Skills
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Barthel Index (BI)
timeFrame: 6 weeks
measure: The Stroke Specific Quality of Life Scale (SSQOL).
timeFrame: 6 weeks
measure: The 6-Minute Walk Test (6MWT)
timeFrame: 6 weeks
measure: The Stair Climbing ascend and descend tests (SCas and SCde)
timeFrame: 6 weeks
Secondary outcomes:
measure: The Fugl-Meyer Assessment (FMA)
timeFrame: 6 weeks
measure: The Comfortable 10-m Walk Test (CWT)
timeFrame: 6 weeks
measure: Rate of Perceived Exertion (RPE)
timeFrame: 6 weeks
measure: The Fast 10-m Walk Test (FWT)
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation Istanbul, Turkey
name: IPEK YELDAN, Assoc.prof
role: STUDY_DIRECTOR
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