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Completed

NCT Number: NCT02247674

Bilateral Movement Training for People With Stroke

The investigators hypothesized that bilateral handgrip force training would result in significant improvements in paretic hand, arm movements and daily functional performances. In order to investigate whether the improvement of paretic hand could facilitate the motor recovery of paretic arm and functional performances, the investigators also hypothesized that motor recovery and functional performances improvements of paretic arm and hand have strongly correlation.

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Key information

Conditions

Stroke Brain Diseases Brain Injuries Brain Injury Cardiovascular Disease Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

28 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

About this study

Objective: To investigate the training effects of interlimb force coupling training on paretic hand and upper extremity outcomes in patients with chronic stroke; to analyze the relationship between motor recovery of paretic hand, arm and functional abilities.

Design: A double-blind randomized controlled trial with outcome assessment at baseline and after 4 weeks intervention.

Setting: Department of physical medicine and rehabilitation in Taipei Veterans General Hospital.

Participants: Thirty-three subjects (mean age = 55.1 ± 10.5 y/o) with chronic stroke were recruited and randomized assigned to training (n=16) and control group (n=17).

Interventions: Interlimb force coupling training task included different gripforce generation on the both hands.

Main Outcome Measures: Barthel Index (BI), and the upper extremity motor control of Fugl-Meyer Assessment (FMA-UE), Motor Assessment Score (MAS), and the Wolf Motor Function Test (WMFT). All assessment was executed by a blinded evaluator, and data management and statistical analysis was also conducted by a blinded statistic researcher.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 6 months since stroke
  • three or fewer incidents of unilateral stroke confirmed by taking the participant's medical history ability to follow researcher's instructions
  • ability to flex and extend the paretic arm and hand
  • Modified Ashworth Score (MAS) ≦3 for wrist and finger joints
  • Mini-Mental State Examination (MMSE) score should 24 or higher
  • no other orthopedic neurological disorders
  • Brunnstrom stage 3 or 4
  • no joint in other experimental rehabilitation or drug studies 21

Exclusion criteria

  • unstable cardiovascular conditions
  • uncontrolled hypertension (190/110 mm Hg)
  • severe orthopedic or pain conditions
  • dementia (Mini-Mental State Examination score < 22)
  • aphasia with inability to follow researcher's commands
  • severe joint contracture of bilateral upper extremities that would impact the movement performances of upper extremities

Treatment and study plan

Bilateral movement training

Procedure

Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)

Other names: Coupling movement

Primary outcomes

  1. Upper Extremity motor control of Fugl-Meyer Assessment (FMA-UE)

    Time frame: before and after 4 weeks intervention

    Outcome measure was assessed before and after 4 weeks intervention.

Secondary outcomes

  1. Barthel Index (BI)

    Time frame: before and after 4 weeks intervention

    Outcome measure was assessed before and after 4 weeks intervention.

  2. Motor Assessment Score (MAS)

    Time frame: before and after 4 weeks intervention

    Outcome measure was assessed before and after 4 weeks intervention.

  3. Wolf Motor Function Test (WMFT)

    Time frame: before and after 4 weeks intervention

    Outcome measure was assessed before and after 4 weeks intervention.

Sponsors and collaborators

Lead sponsor

Chueh-Ho Lin

Other

Collaborators

  • National Yang Ming Chiao Tung University

Registry information

Official study title

Effects of Computer-aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control Following Chronic Stroke

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 25, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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