Clinical trial NCT05689502: intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
Official title: intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Stroke
Keywords: Rehabilitation
Arm recovery
High intensity therapy
Occupational therapy
Physical therapy
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to Investigate the feasibility of a high-quality, high-dose, high-intensity upper extremity therapy program and to assess the treatment effects of a high-quality, high-dose, high-intensity upper extremity therapy program on functional outcomes, motor impairment, and quality of life


Eligibility criteria: Inclusion Criteria:

* Single qualifying stroke event as confirmed by CT or MRI
* At least 6 months post stroke
* Fugl-Meyer upper extremity (UE) score of 20-45
* Able to follow written instructions
* Able to tolerate 6 hours of therapy a day

Exclusion Criteria:

* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
* Active drug or alcohol abuse
* Diagnosed with advanced dementia
* Pre-stroke baseline mRS\>3
* History of clinically significant ischemic or hemorrhagic stroke resulting in prior arm weakness in the same territory as the index stroke
* Medical instability assessed by the treating stroke physician to participate to the study.

Primary outcomes:
measure: Change in integrity of the contralateral corticospinal tract fibers as assessed by the MRI with Diffusion Tensor Imaging (DTI) evaluation
timeFrame: Baseline(1 week prior to intervention),within 1 week after intervention
measure: Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in functional gross and fine motor coordination as assessed by the Action Research Arm Test (ARAT)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Secondary outcomes:
measure: Change in degree of disability as assessed by the Modified Rankin Scale (mRS)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in performance in activities of daily living as assessed by the Barthel Index (BI)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in fatigue as assessed by the Neurological Fatigue Index (NFI)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in depression as assessed by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in functional ability of the hemiplegic arm and hand to perform meaningful tasks as assessed by the Chedoke Arm and Hand Inventory (CAHAI)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in difficulty to care for the affected arm as assessed by the Arm Activity Measure A
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in difficulty in completing functional tasks with the affected arm as assessed by the Arm Activity Measure B
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
measure: Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
Other outcomes:
measure: Number of participants that had a positive perception of the intervention as indicated by the semi structured interview
timeFrame: Once between 6 week and 6 month assessments.
measure: Number of participants that had functional arm improvement after the intervention as indicated by the semi structured interview
timeFrame: Once between 6 week and 6 month assessments.
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Sean Savitz
role: PRINCIPAL_INVESTIGATOR
References: