NCT05515237 Constraint-Induced Movement Therapy Plus Sensory Components After Stroke
| NCT ID | NCT05515237 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | CVA (Cerebrovascular Accident) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-03-30 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-03-30 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
David Morris, PhD
STUDY CHAIR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT05515237 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying CVA (Cerebrovascular Accident). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05515237 currently recruiting?
Yes, NCT05515237 is actively recruiting participants. Contact the research team at mbowman@uab.edu for enrollment information.
Where is the NCT05515237 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT05515237 clinical trial?
NCT05515237 is sponsored by University of Alabama at Birmingham. The principal investigator is David Morris, PhD at University of Alabama at Birmingham. The trial plans to enroll 15 participants.