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Completed

NCT Number: NCT02850042

Comparing Constraint-Induced Therapy and Occupation-Based Intervention for Optimal Stroke Recovery

This pilot study was designed to compare the effects of modified constraint-Induced therapy and occupation-based intervention to increase functional motor recovery in stroke

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The purpose of this study is to investigate change in motor performance and the extent of neuroplastic change associated with both occupation-based intervention and modified constraint-Induced therapy (m-CIT) in the recovery of upper extremity motor function following a stroke. Transcranial Magnetic Imaging (TMS) will be used to compare the difference in the brain reorganization of each client before and after the intervention to identify which technique is more effective in changing brain function. Central Hypothesis: Stroke subjects with motor deficit receiving occupation-based interventions will demonstrate improved motor function greater to that of the subjects receiving m-CIT interventions. Sixteen participants with chronic stroke will be recruited for the study over the age 21. Participants will be randomly assigned to one of the two therapy groups and will receive 55 minutes of therapy 2 times per week for 4 weeks for a total of 8 sessions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 21 years of age and older
  • at least 12 months from stroke
  • mild-to-severe upper extremity motor deficit
  • single ischemic or hemorrhagic stroke

Exclusion criteria

  • history of head injury with loss of consciousness
  • seizures
  • severe alcohol or drug abuse
  • psychiatric illness interfering with participation in the study including uncontrolled depression
  • cognitive deficits severe enough to preclude informed consent
  • ferromagnetic material near the brain
  • individuals that could be pregnant
  • cardiac or neural pacemakers
  • if currently receiving occupational therapy services

Treatment and study plan

Occupation-based practice (OBP)

Behavioral

Modified-constraint induced therapy (m-CIT)

Behavioral

Primary outcomes

  1. Fugl Meyer Assessment (FMA

    Time frame: Score change after 8 days of intervention compared to baseline

Secondary outcomes

  1. Stroke Impact Scale (SIS)

    Time frame: Score change after 8 days of intervention compared to baseline

  2. Canadian Occupational Performance Measure (COPM)

    Time frame: Score change after 8 days of intervention compared to baseline

  3. Goal Attainment Scale (GAS).

    Time frame: Score change after 8 days of intervention compared to baseline

  4. Transcranial Magnetic Stimulation (map volume)

    Time frame: Score change after 8 days of intervention compared to baseline

Sponsors and collaborators

Lead sponsor

Lumy Sawaki

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 29, 2016
Registry last updated
Apr 20, 2017

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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