Providing Sitting Balance Training With a Newly Developed Rehabilitation Device
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This clinical study is being conducted to evaluate a new training device, the T-CHAIR, for
      trunk rehabilitation and post-stroke balance. The investigators would like to study three
      objectives. First, the investigators want to examine whether training with a new training
      device is feasible and safe during rehabilitation in the later phase, more than six months
      after a stroke. The investigators also evaluate whether training with a new training device
      has an effect on the sitting balance and the function and strength of the trunk. Finally, the
      investigators examine whether training with a new training device has an effect on walking,
      standing and activities of daily life and self-care.
    

Detailed description: 
      The primary goal of this study is to evaluate safety, acceptance and feasibility when
      participants in the chronic phase after a stroke train with this newly developed trainings
      device. Secondly, the investigators will evaluate the effect of training with this device on
      secondary outcome parameters such as trunk function, standing and sitting balance, gait and
      selective movement. The investigators compare the effect on secondary outcomes of the
      experimental intervention with a control intervention using a randomized controlled trial.
      Both groups include participants in the chronic phase post-stroke.

      TRIAL OBJECTIVES AND PURPOSE

      The primary objective of the proposed project is to investigate the feasibility and safety of
      sitting balance training on the T-chair, in the chronic phase (>6 months) after stroke.

      The second objective of the study is to investigate if utilizing the T-chair has an effect on
      sitting balance, trunk function and trunk strength in participants post stroke, in comparison
      to conventional therapy.

      Thirdly, the investigators will examine if training on the T-chair has an effect on other
      parameters, such as gait, balance, activities of daily living and reintegration in community.

      TYPE AND DESIGN OF THE TRIAL WITH HYPOTHESIS

      This study is a monocenter randomized controlled trial, evaluating participants in the
      chronic phase (>6 months) after stroke. This study will be performed in a rehabilitation
      center (outpatient department) in Belgium. In this study two groups will be included; the
      experimental group will receive usual therapy plus additional training on the T-chair, the
      control group will receive usual therapy only. The investigators believe this is feasible to
      provide only additional therapy in the experimental group, as our trial is designed to
      examine the effect of a specific type of additional therapy (independent sitting balance
      training), and not to compare the effect of one therapy over another kind of therapy.

      Hypotheses:

        1. The T-chair is a safe and feasible training device, to train trunk function in the
           subacute and chronic phase after stroke.

        2. Training on the T-chair has a positive effect on trunk function and strength compared to
           conventional therapy.

        3. Training on the T-chair has a positive effect on balance, gait, walking endurance,
           walking speed, activities of daily living, level of disability and change in patient
           status compared to conventional therapy.

      ASSESSMENT

      Data such as age, date of stroke, type of stroke, localization of stroke, comorbidities,
      dominant hand, educational level and gender are registered. Testing will be performed three
      times.

      Two test moments at baseline, with an interval of 2 weeks. The third test moment will be
      conducted after the after the four weeks intervention.

      The investigators evaluate feasibility and effect of sitting balance training with different
      standardized measures. All the outcome measures will be assessed using clinical measurement
      tools, whereby the investigators evaluated trunk selectivity and strength, leg selectivity
      and strength, walking abilities, level of functional performance and balance. Trunk strength
      will be assessed with a hand dynanometer and trunk stability with a balance platform
      BioRescue (RM Ingénierie, France).

      The psychometric properties of the majority of the measurement tools were evaluated through a
      literature search. The investigators found a high interrater reliability, ranging from 0.74
      to 0.99 and an excellent test-retest reliability, ranging from 0.90 to 0.99.
    

Intervention name(s): T-chair
Intervention type(s): Device
Intervention description(s): Participants will receive 15 sessions of intervention, four weeks in total with a duration of one hour for each session. The focus of the intervention will be trunk rehabilitation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Rehabilitation; Chronic phase; feasibility; randomized controlled trial