NCT05515237Recruiting
Constraint-Induced Movement Therapy Plus Sensory Components After Stroke
Constraint-Induced Movement Therapy Plus Sensory Components for Adults With Mild-to-Severe Arm and Hand Impairment After Stroke
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 23 Aug 2022
- Start date
- 30 Mar 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Stroke
- NCT number
- NCT05515237
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 30 Mar 2023 to the primary completion date, 31 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- The inability to come in to the laboratory setting for treatment.
Other
- Score\< 24 on the Mini Mental State Exam
- Inability to answer the MAL/ G4/5 MAL questions and/or provide informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.