The Effects of Body Weight Supported Treadmill Training On Balance In Stroke Patients
Condition: Cerebrovascular Stroke; Cerebral Stroke; Cerebrovascular Accident
MeSH terms: Stroke; Body Weight
Study type: Interventional

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:

        1. the combination of BWSTT with conventional training may lead to more improved balance
           parameters;

        2. 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:

      One hundred and seven stroke patient were assessed for eligibility by two physiatrists (B.E
      and B.G). Forty-two (13 women, range of age: 18-75 years) patients were found to be suitable
      for inclusion criteria of the study. Randomisation was performed by using randomisation
      function of Microsoft Office Excel programme by another researcher (ARO). Random number
      generator of Microsoft Office Excel Software gave a random number between 0 and 1 to the each
      treatment columns which were created by ARO. Sorting the random number row from the largest
      to the smallest number was performed by the sort and filter menu. Treatment assignments were
      stratified according to the severity of impairment at baseline and the study site to ensure
      balanced distribution among the three groups.After the randomisation,assessments at baseline
      and after training were performed by two physiotherapists who were blind to the interventions
      (IY, BEH). All the participants were treated in the rehabilitation hospital by a
      physiotherapist who was experienced in stroke rehabilitation. BWSTT Training was performed by
      RM.
    

Intervention name(s): Body Weight Supported Treadmill Training
Intervention type(s): Other
Intervention description(s): There were three intervention arms in this study,
Body Weight Supported Treadmill Training,
Conventional Training and
Combined Training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postural balance; Accidental falls; Rehabilitation; Cerebrovascular Accident; Walking; Mobility limitation