Recruiting

Constraint-Induced Movement Therapy

Sponsor:

University of Alabama at Birmingham

Code:

NCT05492513

Conditions

CVA (Cerebrovascular Accident)

Stroke

Upper Extremity Paresis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Grade 1 CI Therapy +Sensory Components

Study Details

Brief summary:

Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.

Conditions

CVA (Cerebrovascular Accident)

Stroke

Upper Extremity Paresis

Study ID

NCT05492513

Start date

Dec 8, 2022

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 6 months post stroke
  • The ability to demonstrate the minimum UE active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.
  • Mean score of >2.5 on the Motor Activity Log indicating the participant's use of the more-affected UE.

Exclusion Criteria:

  • Score< 24 on the Mini Mental State Exam
  • Inability to answer the MAL questions and/or provide informed consent
  • The inability to come in to the laboratory setting for treatment.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Grade 1 CI Therapy + Sensory Components

All participants will receive the Grade 1 CI Therapy + Sensory Components administered over a two-week period of time.

Interventions

Grade 1 CI Therapy +Sensory Components

All participants will receive Grade 1 CI Therapy + Sensory Components over a two-week period of time. The treatment intervention will include all CI Therapy treatment strategies including: 1) supervised motor training in the form of shaping with repeated trials and task practice for 1.5 hours per day for 5 weekdays for 2 weeks 2) a behavioral Transfer Package (TP) will be employed to aid carry-over of skills gained by the participant in the laboratory to the life situation 3) each participant will wear a mitt on the less-affected hand for most of their waking hours to encourage use of the more-affected hand 4) participants will be given home assignments to be carried out for at least 30 minutes each day. Sensory component strategies will be added to stimulate sensory input through the more-affected arm and hand as well as to train sensory discrimination skills.

Primary outcome measure

  • 45-Item Motor Activity Log (MAL) [ Time Frame: At post treatment after 2 weeks of intervention ]
  • 45-Item Motor Activity Log (MAL) [ Time Frame: At 3 months after the end of the treatment ]
  • Wolf Motor Function Test (WMFT) [ Time Frame: At post treatment after the 2 weeks of intervention ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: At post-treatment after the 2 weeks of intervention ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: At follow-up at 3 months following the end of treatment. ]

Central Contacts and Locations

Central contacts

Mary H Bowman, BS OT

2059340069mbowman@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Mary H Bowman, BS OT

2059340069mbowman@uab.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-02-20.