NCT05492513

Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment

Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment and Deficits in Desired Occupational Performance: A Pilot Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Previous CI therapy studies have explored treatment for participants with varied levels of motor impairment from mild-to-severe that have limited use of the more-affected arm and hand in everyday activities as measured by the Motor Activity Log (MAL). The Motor Activity Log (MAL) is a standardized test used in CI therapy studies to measure the Amount of Use and the Quality of Use of the more-affected UE in the life situation. Individuals that exceed maximal criteria with a mean MAL score higher than 2.5 are typically excluded from CI therapy studies since they potentially would hit a ceiling effect on the MAL and would not be able to show a meaningful treatment change. Similarly, in a clinical setting, these individuals are often discharged from outpatient therapy as having reached the maximum benefit of traditional therapy since each can typically perform basic skills with the more-affected UE despite the disparity of continued difficulty with performing high-level motor tasks and persistent sensory deficits. However, these patients often voice strong motivation to gain more recovery and return to performing activities of daily living (ADL) and instrumental activities of daily living (IADL)that require complex motor skills (i.e.; keyboarding, texting, utensil or tool use, musical instrument use, etc). We hypothesize that participants with mild UE movement deficits will benefit from CI therapy with focused intervention to address skills and performance of high-level tasks and outcome measures that are selected for this level of patient. We further question if adding sensory components to the CI therapy strategies will improve the participant's sensation for the more-affected UE and aid in the more-affected UE use in everyday tasks but particularly in challenging motor tasks.

Conditions

• CVA (Cerebrovascular Accident)
• Stroke
• Upper Extremity Paresis

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2022-12-08
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2022-08-08
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States