Clinical trial NCT05492513: Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment
Official title: Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment and Deficits in Desired Occupational Performance: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Stroke
Upper Extremity Paresis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 45-Item Motor Activity Log (MAL)
timeFrame: At post treatment after 2 weeks of intervention
measure: 45-Item Motor Activity Log (MAL)
timeFrame: At 3 months after the end of the treatment
measure: Wolf Motor Function Test (WMFT)
timeFrame: At post treatment after the 2 weeks of intervention
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: At post-treatment after the 2 weeks of intervention
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: At follow-up at 3 months following the end of treatment.
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: At post- treatment following the 2 weeks of treatment
measure: Beck Depression Inventory (BDI)
timeFrame: At 3 month follow up from the end of the 2 weeks of treatment.
measure: Stroke Impact Scale (SIS)
timeFrame: At post-treatment following the 2 weeks of treatment
measure: Stroke Impact Scale (SIS)
timeFrame: At 3 months following the end of the 2 weeks of treatment.
measure: 9 Hole Peg Test (9HPT)
timeFrame: At post-treatment after the 2 weeks of intervention
measure: Revised Nottingham Sensory Assessment (rNSA)
timeFrame: At post-treatment after the 2 weeks of intervention
measure: Semmes-Weinstein Monofilament Test (SWMT)
timeFrame: At post-treatment after the 2 weeks of intervention
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: David Morris, PhD
role: STUDY_CHAIR
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