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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Cerebrovascular Accidents

Treatments

Other: Home-based BAT
Other: Home-based mCIT
Other: Hospital-based TR
Other: Home-based TR
Other: Hospital-based mCIT
Other: Hospital-based BIT

Study type

Interventional

Funder types

Other

Identifiers

NCT00778453
96-1754B (Other Identifier)
NSC97-2314-B-182-004-MY3

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 patients

Sex

All

Ages

35 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 6 patient groups

Hospital-based mCIT
Experimental group
Description:
Hospital-based modified constraint-induced therapy(mCIT)
Treatment:
Other: Hospital-based mCIT
Hospital-based BIT
Experimental group
Description:
Hospital-based bilateral isokinematic training (BIT)
Treatment:
Other: Hospital-based BIT
Hospital-based TR
Experimental group
Description:
Hospital-based traditional rehabilitation (TR)
Treatment:
Other: Hospital-based TR
Home-based BAT
Experimental group
Description:
Home-based bilateral arm training(BAT)
Treatment:
Other: Home-based BAT
Home-based TR
Experimental group
Description:
Home-based traditional rehabilitation (TR)
Treatment:
Other: Home-based TR
Home-based mCIT
Experimental group
Description:
Home-based modified constraint-induced therapy (mCIT)
Treatment:
Other: Home-based mCIT

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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