Constraint-Induced Movement Therapy Plus Sensory Components After Stroke

NCT ID: NCT05515237

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-30
• Study Completion Date: 2026-06-30

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.

Detailed Description

The purpose of this study is to systematically examine the feasibility of adding somatosensory components to CI Therapy protocols for patients having mild-to-severe impairment to improve more-affected UE use, motor ability, and sensory perception in the chronic phase of stroke recovery. Treatment will follow previous timeframes of CI Therapy protocols of 2 weeks of intervention for mild-to-moderate UE impairment and 3 weeks for severe UE impairment. The Motor Activity Log (MAL) and Grade 4/5 Motor Activity Log (G4/5 MAL) are used to measure use of the more affected UE by participants with mild-to-moderate impairment and severe impairment, respectively. Motor capacity is measured by the Wolf Motor Function Test (WMFT) for those with mild-to-moderate impairment and the Grade 5 - Graded Wolf Motor Function Test (G5-GWMFT) for those with severe UE impairment. Participants: 15 post-stroke participants in the chronic phase of recovery (at least 6 months post-stroke) will be enrolled. Participants in this study must at least meet the minimal motor criteria for severely impaired participants. Thus, prior to treatment, participants must be able to demonstrate movement more-affected UE including the ability to move the shoulder ≥ 30 toward flexion or abduction, initiate movement at the elbow for flexion and extension, and initiate movement at the wrist, fingers, or thumb. Outcome Measures: Aim 1 will be assessed using the MAL (Arm use) for mild-to-moderately impaired participants or the G4/5 MAL (Arm use) for severely impaired participants, WMFT (UE motor capacity) for mild-to-moderately impaired and G5-GWMFT (UE motor capacity) for severely impaired participants, SIS (Stroke Impact Scale - Quality of Life), Zung Depression Scale (ZDS-Mood), and Canadian Occupational Performance Measure (COPM - Functional activity preference, ability and satisfaction). All measures will be administered immediately pre-treatment and at post-treatment. The MAL or G4/5 MAL, SIS, COPM, and ZDS will also be administered at 3 months post-intervention by telephone. Aim 2 will be assessed by Revised Nottingham Sensory Assessment (rNSA-Sensation) and Semmes & Weinstein Monofilament Test (SWMT- Sensation). These measures will be performed immediately pre-treatment and at post-treatment. Intervention: Participants will receive CI therapy plus somatosensory training components for the more-affected upper extremity for 2-3 weeks (depending on the level of UE impairment severity) for 3.5 hours per weekday. Specific CI therapy strategies will be delivered as is described with the addition of somatosensory components for the more-affected arm and hand. CI therapy strategies include: 1.) supervised movement training for 3.5 hours 5 weekdays x 2-3 weeks; 2.) participants will wear a restraint mitt on the less-affected hand for the majority of their waking hours for the 2-3 weeks; 3.) a transfer package will be used to help the participant transfer their gains from the laboratory to the life situation. Sensory components may be used to increase sensory input to the brain and increase the attention of each participant to the more-affected UE. The sensory components may include 1.) sensory stimulation to the more-affected UE (e.g.; brushing the UE with soft bristle brush, vibration to the finger tips, massage to the UE, etc); 2.) sensory training tasks that require each participant to respond to what is felt through the UE (e.g.; object identification, temperature discrimination, material identification, etc.)

Conditions

CVA (Cerebrovascular Accident); Stroke; Upper Extremity Paresis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Grade 2-5 CI Therapy + Sensory Components

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Mary H Bowman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Morris, PhD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mary Bowman, BS OT

Role: CONTACT

mbowman@uab.edu

2059340069

Facility Contacts

Mary H Bowman, BS OT

Role: primary

mbowman@uab.edu

2059340069

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Other Identifiers

IRB-300009729

Identifier Type: -

Identifier Source: org_study_id