Clinical trial NCT05515237: Constraint-Induced Movement Therapy Plus Sensory Components After Stroke
Official title: Constraint-Induced Movement Therapy Plus Sensory Components for Adults With Mild-to-Severe Arm and Hand Impairment After Stroke
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: 2022-08-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.)

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.

Primary outcomes:
measure: Motor Activity Log
timeFrame: At post treatment after 2 weeks of intervention for participants with mild-moderate UE impairment
measure: Motor Activity Log
timeFrame: At 3 month follow up after the end of treatment
measure: G4/5 Motor Activity Log
timeFrame: At post treatment after 3 weeks of intervention for participants with severe UE impairment
measure: G4/5 Motor Activity Log (G4/5 MAL)
timeFrame: At 3 month follow up after the end of treatment
measure: Wolf Motor Function Test(WMFT)
timeFrame: At post treatment after the 2 weeks of intervention for mild to moderately impaired participants
measure: Grade 5 Graded Wolf Motor Function Test (G5 GWMFT)
timeFrame: At post treatment after the 3 weeks of intervention for severely impaired participants
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: At post treatment after the 2-3 weeks of intervention, depending on the severity of the impairment.
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: At 3 month follow up after the end of treatment
Secondary outcomes:
measure: Zung Depression Scale (ZDS)
timeFrame: At post treatment after 2-3 weeks of treatment, depending on the severity of the impairment
measure: Zung Depression Scale (ZDS)
timeFrame: At 3 month followup after the end of treatment.
measure: Stroke Impact Scale (SIS)
timeFrame: At post-treatment following the 2-3 weeks of treatment, depending on severity of the impairment.
measure: Stroke Impact Scale (SIS)
timeFrame: At 3 months follow-up after the end of treatment.
measure: Revised Nottingham Sensory Assessment (rNSA)
timeFrame: At post-treatment after 2-3 weeks of treatment, depending in the severity of the impairment
measure: Semmes-Weinstein Monofilament Test (SWMT)
timeFrame: At post-treatment after the 2-3 weeks of intervention, depending on the level of impairment
measure: Participant Opinion Survey (PO Survey)
timeFrame: At post-treatment after the 2-3 weeks of intervention, depending on the level of impairment
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
References:
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