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Completed

NCT Number: NCT00778453

Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients

The findings of this study will advance movement reorganization mechanism underlying treatment approaches and clinical intervention techniques. These findings may inform rehabilitation professionals about which treatment approach is superior to another one in certain aspect of outcome and who can benefit most from certain treatment approach. Accordingly, the results of this project may help us move quickly to design and develop efficient and effective rehabilitation programs for individualized patients.

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Key information

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kwei-shan, Toayuan, Taiwan

About this study

The first purpose is to investigate the relative effects of modified constraint-induced therapy (mCIT) vs. bilateral isokinematic training (BIT) vs. traditional or therapist-based training (TR) on movement reorganization, motor performance, functional ability, and quality of life (QoL) immediately and six months later after treatment delivered at hospitals. Movement reorganization will be evaluated by kinematic instrument. Motor performance, functional ability, and QoL will be assessed using clinical assessment tools. By the same token, we also investigate the relative effects of these two approaches delivered at home. The second purpose is to study whether home-based mCIT is efficacious in various aspects of outcomes described above immediately and six months later following treatment, compared to home-based TR, and hospital-based mCIT and TR.We also study the same question regarding home-based BIT efficacy. The third purpose is to establish predictive models to predict functional and QoL outcomes immediately and six months later following mCIT and BIT.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • the onset duration more than 6 months
  • Brunnstrom stage III above for the proximal part and distal part of UL
  • no serious cognitive deficits
  • no balance problems sufficient to compromise safety when wearing the project's constraint device
  • no excessive spasticity in any of the joints of the affected UL exclusion criteria:
  • a score of less than 24 on the Mini Mental State Exam

Treatment and study plan

Hospital-based mCIT

Other

restraint of the unaffected arm and practice of the affected arm

Other names: Hospital-based modified constraint-induced therapy(mCIT)

Hospital-based BIT

Other

bilateral symmetric, repetitive arm training

Other names: Hospital-based bilateral isokinematic training (BIT)

Hospital-based TR

Other

hospital-based traditional rehabilitation : OT or PT or therapist-based training

Other names: Hospital-based traditional rehabilitation (TR)

Home-based mCIT

Other

restraint of the unaffected arm and practices of the affected arm

Other names: Home-based modified constraint-induced therapy (mCIT)

Home-based BAT

Other

bilateral symmetric, repetitive arm training

Other names: Home-based bilateral arm training (BAT)

Home-based TR

Other

home-based traditional rehabilitation:OT or PT or therapist-based training

Other names: Home-based traditional rehabilitation (TR)

Primary outcomes

  1. kinematic analysis

    Time frame: 2008-2011

Secondary outcomes

  1. clinical measures

    Time frame: 2008-2011

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Health Research Institutes, Taiwan
  • National Science and Technology Council, Taiwan

Registry information

Official study title

Relative Effects and Predictive Models of Contemporary Upper Limb Training Programs in Stroke Patients Delivered in Hospital-based and Home-based Settings

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 23, 2008
Registry last updated
Aug 2, 2012

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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