None listed
Conditions
Brief summary
This project is a pilot trial of a novel, non-robotic training device, the SMART Arm, to retrain upper limb function in stroke survivors with severe paresis. The aim of the trial is to determine the extent to which training of reaching using the SMART Arm with outcome triggered electrical stimulation, will lead to improvements in upper limb function for stroke survivors with severe upper limb paresis who are in the acute stage of recovery. In a pilot randomised control trial, 12 inpatients undertaking rehabilitation at The Townsville Hospital and who have had a first ever stroke within the previous three months will be recruited to the study. The participants will be randomly allocated to Intervention A or Intervention B groups. Participants allocated to the Intervention A will receive SMART Arm training WITH electrical stimulation and 30 minutes of usual care for 30 minutes per day, five days a week for four weeks. Participants allocated to Intervention B will receive 30 minutes of SMART Arm training WITHOUT electrical stimulation and 30 minutes of usual care, five days a week for four weeks. All training will be provided by Occupational Therapy staff of The Townsville Hospital rehabilitation unit. Pre-intervention and post-intervention assessment of arm impairment and activity will be undertaken by a blinded assessor. Study outcomes will be used to refine the training device and protocol and to estimate the required sample size for a follow-up RCT.
Interventions
Participants will undertake 20 training sessions (5 per week) to achieve 60-80 repetitions of reaching per session over a four week period using the SMART Arm with outcome triggered electrical stimulation. Training sessions will be conducted individually and administered by the treating physiotherapist or occupational therapist who has received training in use of the SMART Arm.
The SMART Arm (Sensory Motor Active Rehabilitation Training of the Arm) is a novel, non-robotic training device that
Participants will undertake 20 training sessions (5 per week) to achieve 60-80 repetitions of reaching per session over a four week period using the SMART Arm with outcome triggered electrical stimulation. Training sessions will be conducted individually and administered by the treating physiotherapist or occupational therapist who has received training in use of the SMART Arm. The SMART Arm (Sensory Motor Active Rehabilitation Training of the Arm) is a novel, non-robotic training device that is specifically designed so that stroke survivors with little muscle activity can practice a reaching task along a straight line path, consistent with a normal reaching pattern. The SMART Arm can be used with or without outcome triggered electrical stimulation. Outcome triggered electrical stimulation means that when the stroke survivor reaches a preset reaching distance the SMART Arm will trigger delivery of electrical stimulation to the triceps muscle to assis the stroke survivor to complete the reaching task through full range.
Sponsors
James Cook University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
First ever stroke less than 3 months previously Less than grade 3 triceps muscle strength An inability to perform a standardised reaching task and Able to understand instructions and provide informed consent
Exclusion criteria
Upper extremity comorbidities with the potential to limit function An inability to tolerate electrical stimulation or Medically unstable
Outcome results
None listed