Neurophysiological and Kinematic Predictors of Response in Chronic Stroke "SRT4"

Not yet recruiting

Phase 2 Results N/A

Trial Description

The purpose of this study is to design a predictive model of stroke recovery based on baseline measurements of arm movement and brain physiology. The expectation is the development of a formula to predict a person's response to an arm rehabilitation program provided in the chronic phase (6 months or greater post stroke) of recovery. The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic testing using saliva, and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).

Detailed Description

After informed consent, a baseline neurological exam, MRI of the brain, TMS, questionnaires, cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing will occur in the first 4-6 weeks of participation including three separate sessions approximately 1 week a part to examine arm strength, range of motion, and ability to perform functional tasks. Additionally, one robot evaluation, one MRI and two TMS sessions will be completed. We will also collect genetic data using a saliva sample to examine potential genetic polymorphisms that might influence response to therapy.
The intervention phase consists of 12 weeks of robot and arm exercise training (TTT). Interventions will occur 3 times per week for 12 weeks for a total of 36 visits. Additional time and visits will be allowed with visits occurring 4 times per week or up to 4 additional weeks (not to exceed 16 weeks) if scheduling conflicts arise. The intervention sessions will be one hour in duration.
During the hour long intervention, 45 minutes of robotic intervention will be followed by 15 minutes of TTT. Two separate robots targeting different movements will be used for the 3 phases of the robot training. The training will be sequential with 12 sessions completed on the wrist robot, followed by 12 sessions on the shoulder-elbow robot and the final 12 sessions alternating between the wrist and elbow-shoulder robot.

Conditions

Interventions

  • Robot + TTT exercise Device
    Intervention Desc: The intervention will be completed 3x/week for 12 weeks. The training progression will be sequential with 4 weeks completed on the wrist robot, followed by 4 weeks on the shoulder-elbow robot and completing with 4 weeks alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
    ARM 1: Kind: Experimental
    Label: Device: Robot + TTT Exercise
    Description: All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Stroke Impact Scale: Hand Baseline, and 12 weeks No
Primary Fugl-Meyer Upper Extremity Assessment Baseline, and 12 weeks No
Secondary Action Research Arm Test (ARAT) Baseline, and 12 weeks No
Secondary 6-Item Wolf Motor Function Test (WMFT) Baseline, and 12 weeks No

Sponsors