Recruiting

Constraint-Induced Movement Therapy

Sponsor:

University of Alabama at Birmingham

Code:

NCT05515237

Conditions

CVA (Cerebrovascular Accident)

Stroke

Upper Extremity Paresis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Grade 2-5 CI Therapy + Sensory Components

Study Details

Brief summary:

Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically employs the application of selected behavioral techniques delivered in intensive treatment over consecutive day with the following strategies utilized: behavioral strategies are implemented to improve the use of the more- affected limb in life situation called a Transfer Package (TP), motor training using a technique called shaping to make progress in successive approximations, repetitive, task oriented training, and strategies to encourage or constrain participants to use the more-affected extremity including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use and the quality of the more-affected UE functional use in the participant's daily life situation.

CI Therapy studies with adults, to date, have explored intensive treatment for participants with a range from mild-to-severe motor impairment following stroke with noted motor deficits and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy protocol was designed for the level of impairment demonstrated by participants recruited for the study. However, often following stroke, patients not only have motor deficits but somatosensory impairments as well. The somatosensory issues have not, as yet, been systematically measured and trained in CI Therapy protocols with adults and represent an understudied area of stroke recovery. We hypothesize that participants with mild-to-severe motor impairment and UE functional use deficits can benefit from CI therapy protocols that include somatosensory measurement and training components substituted for portions of motor training without loss in outcome measure gains. Further, we hypothesize that adults can improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory component protocol.

Conditions

CVA (Cerebrovascular Accident)

Stroke

Upper Extremity Paresis

Study ID

NCT05515237

Start date

Mar 30, 2023

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • At least 6 months post stroke
  • The ability to demonstrate the minimum UE active movement criteria of shoulder ≥ 30 toward flexion or abduction, initiate movement at the elbow for flexion and extension, and initiate movement at the wrist, fingers, or thumb.
  • Mean score of <2.5 on the Motor Activity Log/ G4/5 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/ G4/5 MAL questions and/or provide informed consent
  • The inability to come in to the laboratory setting for treatment.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Grade 2-5 CI Therapy + Sensory Components

All participants will receive CI Therapy + Sensory Components administered over the specific time frame of 2-3 weeks.

Interventions

Grade 2-5 CI Therapy + Sensory Components

All participants will receive CI Therapy + Sensory Components over a 2-3 weeks time frame. The treatment intervention will apply all CI Therapy treatment components to include: 1) a behavioral set of techniques called the Transfer Package (TP) to promote carry-over of skills that were gained in the laboratory into the participant's life situation, 2) the use of motor training called shaping to make progress in small approximations 3) the use by the participant of a mitt on the less-affected hand to encourage use of the more-affected hand and 4) home skills and home work will be provided each day for at least 30 minutes. Sensory component training strategies will be added to stimulate sensory input through the more-affected arm an dhand as well as to train sensory discrimination skills.

Primary outcome measure

  • Motor Activity Log [ Time Frame: At post treatment after 2 weeks of intervention for participants with mild-moderate UE impairment ]
  • Motor Activity Log [ Time Frame: At 3 month follow up after the end of treatment ]
  • G4/5 Motor Activity Log [ Time Frame: At post treatment after 3 weeks of intervention for participants with severe UE impairment ]
  • G4/5 Motor Activity Log (G4/5 MAL) [ Time Frame: At 3 month follow up after the end of treatment ]
  • Wolf Motor Function Test(WMFT) [ Time Frame: At post treatment after the 2 weeks of intervention for mild to moderately impaired participants ]
  • Grade 5 Graded Wolf Motor Function Test (G5 GWMFT) [ Time Frame: At post treatment after the 3 weeks of intervention for severely impaired participants ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: At post treatment after the 2-3 weeks of intervention, depending on the severity of the impairment. ]
  • Canadian Occupational Performance Measure (COPM) [ Time Frame: At 3 month follow up after the end of treatment ]

Central Contacts and Locations

Central contacts

Mary 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

Apr 13, 2026

Last verified

Apr, 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 2026-04-13.