Clinical trial NCT05311384: Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity
Official title: Application of a Reimbursable Form of Constraint-Induced Movement Therapy for Upper Extremity Recovery Following Stroke: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CVA (Cerebrovascular Accident)
Stroke
Upper Extremity Paresis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CI therapy is a family of techniques that has systematically applied intensive treatment daily over consecutive days, supervised motor training using a technique called shaping, behavioral strategies to improve the use of the more- affected limb in real life situations called a Transfer Package (TP), and strategies to remind participants to use the more-affected extremity; including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining use of CI therapy with UE rehabilitation have demonstrated robust evidence for increasing the amount and the quality of the paretic UE functional use in daily situations of individuals recovering from stroke.

Previous studies have explored the barriers for clinical implementation of the approach, including the amount of time needed by therapists, other resources required and lack of payment for the services. With regards to therapists' time/resources, in the signature CI therapy protocol, therapists supervised movement training for 3 hours daily (except for weekends) for a 12 consecutive-day period. This level of supervision in highly unusual for traditional rehabilitation clinical settings. The treatment schedule is also incompatible with most insurance reimbursement policies in the US. As such, most CI therapy clinics require patients to pay privately with little or no insurance reimbursement. Such practices severely limit the number of patients who can afford to receive CI therapy. Two lines of evidence have suggested that an alternative CI therapy protocol may allow for the essential (or "Key") CI therapy elements to be delivered in a schedule that better utilizes therapist time/resources and is compatible with payment policies of many US insurance companies. One line of evidence comes from findings that indicate that the original 6-hour supervised training schedule could be shortened to as little as 2-hours/daily without a reduction in outcomes. Additional evidence comes from a study exploring the systematic addition and deletion of the signature CI therapy protocol elements indicated that when the transfer package was omitted, outcomes related to functional use were reduced by 50%. These findings were also verified by brain imaging studies conducted concurrently that revealed a much-reduced level of brain remodeling in those not receiving the transfer package. These findings highlight the potential effectiveness of the transfer package and continued movement training by the patient while away from clinical supervision. The hypothesis of this study is that the amount of supervised training could be reduced further and delivered in a distributed schedule (1 to 4 times/ week over an 8-week period) instead of consecutively over a 12-day treatment period. This modification could be possible by adapting and strengthening the transfer package component of the protocol. In order to investigate if all of the Keys intervention protocol is necessary for producing optimal outcomes, the delivery of specific protocol elements will be also explored. Additionally, another round of testing at the 4-week point of the 8-week intervention will be administered to investigate the need for the final 4 weeks of the intervention.


Eligibility criteria: Inclusion Criteria:

* At least 6 months after stroke
* Ability to demonstrate minimum movement criteria of more-affected UE including 10 degrees of wrist extension (starting from a fully flexed position), 10 degrees of thumb abduction, and 10 degrees of extension of two additional fingers at all joints
* Score \<2.5 on the MAL indicating significant functional deficits of the more-affected UE

Exclusion Criteria:

* Inability to answer the MAL questions and/or provide informed consent
* Score \<24 on the Mini-Mental State Examination
* No availability to come to the clinic for the sessions.

Primary outcomes:
measure: Motor Activity Log (MAL)
timeFrame: Pre-treatment
measure: Motor Activity Log (MAL)
timeFrame: 4 weeks after starting the intervention (middle of the protocol)
measure: Motor Activity Log (MAL)
timeFrame: after the intervention (8 weeks after starting the protocol)
measure: Motor Activity Log (MAL)
timeFrame: 3 months after the end of the treatment.
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Pre-treatment
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 4 weeks after starting the intervention (middle of the protocol)
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: after the intervention (8 weeks after starting the protocol)
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 3 months after the end of the treatment.
measure: Wolf Motor Function Test (WMFT) - Performance Time
timeFrame: Pre-treatment
measure: Wolf Motor Function Test (WMFT) - Performance Time
timeFrame: 4 weeks after starting the intervention (middle of the protocol)
measure: Wolf Motor Function Test (WMFT) - Performance Time
timeFrame: after the intervention (8 weeks after starting the protocol)
measure: Wolf Motor Function Test (WMFT) - Functional Ability Scale
timeFrame: Pre-treatment
measure: Wolf Motor Function Test (WMFT) - Functional Ability Scale
timeFrame: 4 weeks after starting the intervention (middle of the protocol)
measure: Wolf Motor Function Test (WMFT) - Functional Ability Scale
timeFrame: after the intervention (8 weeks after starting the protocol)
Secondary outcomes:
measure: Stroke Impact Scale (SIS)
timeFrame: Pre-treatment
measure: Stroke Impact Scale (SIS)
timeFrame: 4 weeks after starting the intervention (middle of the protocol)
measure: Stroke Impact Scale (SIS)
timeFrame: after the intervention (8 weeks after starting the protocol)
measure: Stroke Impact Scale (SIS)
timeFrame: 3 months after the end of the treatment.
measure: Zung Self-Rating Depression Scale
timeFrame: Pre-treatment
measure: Zung Self-Rating Depression Scale
timeFrame: 4 weeks after starting the intervention (middle of the protocol)
measure: Zung Self-Rating Depression Scale
timeFrame: after the intervention (8 weeks after starting the protocol)
measure: Zung Self-Rating Depression Scale
timeFrame: 3 months after the end of the treatment.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
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