Does Isolated Robotic-Assisted Gait Training Improve Functional Status, Daily Living And Quality Of Life In Stroke?
Condition: Cerebrovascular Stroke; Cerebrovascular Accident; Cerebral Stroke
MeSH terms: Stroke
Study type: Interventional

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.
    

Intervention name(s): Robotic-Assisted Gait Training
Intervention type(s): Other
Intervention description(s): There were three intervention arms in this study,
Robotic-Assisted Gait Training,
Conventional Training,
Combined Training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rehabilitation; Gait; Ambulation; Exercise Therapy; Physical Exertion; Motor Skills