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

NCT02850042 | Completed Phase 2

• 1 other identifier: 13-0509
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Stroke; Cerebrovascular Accident

Keywords

motor recovery; human; occupation-based practice; motor training; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment (FMA

  Score change after 8 days of intervention compared to baseline

Secondary Outcomes (4)

• Stroke Impact Scale (SIS)

  Score change after 8 days of intervention compared to baseline

• Canadian Occupational Performance Measure (COPM)

  Score change after 8 days of intervention compared to baseline

• Goal Attainment Scale (GAS).

  Score change after 8 days of intervention compared to baseline

• Transcranial Magnetic Stimulation (map volume)

  Score change after 8 days of intervention compared to baseline

Study Arms (2)

Occupation-based practice

EXPERIMENTAL

Occupation-based intervention (OBP) is a form of activity-based therapy consisting of client-directed occupations that match client-identified goals. OBP group will participate in activities such as wood working, scrap booking, higher level dressing (don/doffing a bra, zipping coat), hair care, opening doors, using bathroom stalls, typing, cooking, tying shoes, washing dishes, carrying dirty dish carts, clearing dirty dishes and raking. Repetition of the tasks are not the focus in the OBP group. Each session lasted 55-minute and it was delivered twice a week for 4 weeks (8 sessions).

Behavioral: Occupation-based practice (OBP)

Modified-constraint induced therapy

ACTIVE COMPARATOR

Modified-constraint induced therapy (m-CIT) group will target functional goals (eg, activities of daily living) or goal subcomponents (eg, pinching, grasp/release, or functional reach patterns). Tasks were repeated at rate of approximately 10 to 50 repetitions each session according to the demands of the task. No physical constraint of the less-affected UE will be applied, but training compelled highly repetitive use of the more-affected upper extremity. Subjects will attempt tasks with progressive difficulty. Each session lasted 55-minute and it was delivered twice a week for 4 weeks (8 sessions).

Behavioral: Modified-constraint induced therapy (m-CIT)

Interventions

Occupation-based practice (OBP) BEHAVIORAL

Occupation-based practice

Modified-constraint induced therapy (m-CIT) BEHAVIORAL

Modified-constraint induced therapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumy Sawaki: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor,department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: July 27, 2016
• First Posted: July 29, 2016
• Study Start: June 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 20, 2017

Record last verified: 2017-04