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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02850042
• Other study ID #: 13-0509
• Status: Completed
• Phase: Phase 2
• First received: July 27, 2016
• Last updated: April 18, 2017
• Start date: June 2013
• Est. completion date: May 2016

Study information

• Verified date: April 2017
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Occupation-based practice (OBP)

• Modified-constraint induced therapy (m-CIT)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lumy Sawaki

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment (FMA		Score change after 8 days of intervention compared to baseline
Secondary	Stroke Impact Scale (SIS)		Score change after 8 days of intervention compared to baseline
Secondary	Canadian Occupational Performance Measure (COPM)		Score change after 8 days of intervention compared to baseline
Secondary	Goal Attainment Scale (GAS).		Score change after 8 days of intervention compared to baseline
Secondary	Transcranial Magnetic Stimulation (map volume)		Score change after 8 days of intervention compared to baseline