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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Robotic-assisted gait training Other
    Intervention Desc: There were three intervention arms in this study, Robotic-Assisted Gait Training, Conventional Training, Combined Training.
    ARM 1: Kind: Experimental
    Label: Robotic-Assisted Gait Training
    Description: Locomat (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.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary The Barthel Index (BI) 6 weeks No
Primary The Stroke Specific Quality of Life Scale (SSQOL). 6 weeks No
Primary The 6-Minute Walk Test (6MWT) 6 weeks No
Primary The Stair Climbing ascend and descend tests (SCas and SCde) 6 weeks No
Secondary The Fugl-Meyer Assessment (FMA) 6 weeks No
Secondary The Comfortable and the Fast 10-m Walk Test (CWT and FWT) 6 weeks No
Secondary Rate of Perceived Exertion (RPE) 6 weeks No
Secondary The Comfortable 10-m Walk Test (CWT) 6 weeks No
Secondary The Fast 10-m Walk Test (FWT) 6 weeks No

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