No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 89
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for people who have had a stroke at least 6 months ago and have difficulty using their affected arm. Participants will receive intense therapy aimed at improving the use of their weaker arm through specific exercises and techniques.
Are You a Good Fit for This Trial?
You may be able to join if
I have had a stroke at least 6 months ago.
I can move my shoulder at least 30 degrees.
I can start moving my elbow up and down.
I can start moving my wrist, fingers, or thumb.
I use my affected arm less than I should in daily activities.
You may not be able to join if
I scored less than 24 on the Mini Mental State Exam.
I cannot answer questions about my arm's use.
I cannot give informed consent.
I cannot come to the lab for treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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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…
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.
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