Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham
About this trial
Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 6 months post stroke
The ability to demonstrate the minimum UE active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.
Mean score of >2.5 on the Motor Activity Log indicating the participant's use of the more-affected UE.
Disqualifiers
Score< 24 on the Mini Mental State Exam
Inability to answer the MAL questions and/or provide informed consent
The inability to come in to the laboratory setting for treatment.
Trial design
Design model
Single group
Treatments tested in this trial
Grade 1 CI Therapy +Sensory Components
BehavioralAll participants will receive Grade 1 CI Therapy + Sensory Components over a two-week period of time. The treatment intervention will include all CI Therapy treatment strategies including: 1) supervised motor training in the form of shaping with repeated trials and task practice for 1.5 hours per day for 5 weekdays for 2 weeks 2) a behavioral Transfer Package (TP) will be employed to aid carry-over of skills gained by the participant in the laboratory to the life situation 3) each participant will wear a mitt on the less-affected hand for most of their waking hours to encourage use of the more-affected hand 4) participants will be given home assignments to be carried out for at least 30 minutes each day. Sensory component strategies will be added to stimulate sensory input through the more-affected arm and hand as well as to train sensory discrimination skills.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Grade 1 CI Therapy + Sensory ComponentsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
45-Item Motor Activity Log (MAL)
The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).
Time frame
At post treatment after 2 weeks of intervention2
45-Item Motor Activity Log (MAL)
The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).
Time frame
At 3 months after the end of the treatment3
Wolf Motor Function Test (WMFT)
The WMFT is a standardized test that measures the motor ability of the upper extremities of a participant. The performance time by stopwatch is recorded and functional ability (quality) score is provided for each item tested. It is administered before treatment and after treatment. The quality of movement is rated by the therapist on a scale from 0-5 with 0 representing the participant's inability to perform the task, and 5 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance represents a better performance.
Time frame
At post treatment after the 2 weeks of intervention4
Canadian Occupational Performance Measure (COPM)
The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.
Time frame
At post-treatment after the 2 weeks of interventionSecondary outcomes
1
Beck Depression Inventory (BDI)
The BDI is a self-reported test with 21 items that measures the symptoms of depression. Scores range from 1-40+ with 11-16 as mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 extreme depression. The BDI administered before treatment, after treatment, and in follow up at 3 months out from treatment to detect changes in mood.
Time frame
At post- treatment following the 2 weeks of treatment2
Beck Depression Inventory (BDI)
The BDI is a self-reported test with 21 items that measures the symptoms of depression. Scores range from 1-40+ with 11-16 as mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 extreme depression. The BDI administered before treatment, after treatment, and in follow up at 3 months out from treatment to detect changes in mood.
Time frame
At 3 month follow up from the end of the 2 weeks of treatment.3
Stroke Impact Scale (SIS)
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Time frame
At post-treatment following the 2 weeks of treatment4
Stroke Impact Scale (SIS)
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Time frame
At 3 months following the end of the 2 weeks of treatment.Sponsors and contacts
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Source ClinicalTrials.gov