None listed
Conditions
Brief summary
The primary aim of this study is to investigate whether five weeks of up to one hour daily of early, active, repetitive motor training in addition to usual upper limb therapy can prevent upper limb contractures after stroke or other types of ABI. Secondary aims are to determine the effect of this intervention on upper limb function and upper limb pain, and to investigate patients’ perspectives of the intervention. The study will be a parallel group, randomized controlled trial, with blinding of assessors and concealed randomization. Pre-intervention outcome measures will be taken prior to participants being randomized into either the experimental or the control group. Participants in the experimental group will receive a maximum of 1 hour a day of early active repetitive motor training using the SMART Arm device plus usual upper limb therapy, five days a week, for five weeks, in addition to the usual upper limb therapy. Participants in the control group will receive usual upper limb therapy only. The intervention will cease at the end of 5 weeks and outcome measures for both groups will be collected at that time. Follow-up outcome measures will be collected at 7 weeks. Qualitative interviews with ten participants from the experimental group will be undertaken at the end of the intervention period.
Interventions
Early active repetitive motor training for a maximum of 1 hour per day, in addition to usual upper limb therapy programs, 5 days a week for 5 weeks. Early active repetitive motor training will be delivered using the SMART Arm device. The SMART Arm is a non-robotic device which enables intensive and repetitive reaching practice by patients with severe upper limb weakness. Training using the SMART Arm will involve repeatedly practicing a reaching task by pushing the arm along a track to reach a go
Early active repetitive motor training for a maximum of 1 hour per day, in addition to usual upper limb therapy programs, 5 days a week for 5 weeks. Early active repetitive motor training will be delivered using the SMART Arm device. The SMART Arm is a non-robotic device which enables intensive and repetitive reaching practice by patients with severe upper limb weakness. Training using the SMART Arm will involve repeatedly practicing a reaching task by pushing the arm along a track to reach a goal e.g. to reach to a goal line or grasp an object. to help the participant achieve the movement, electrical stimulation may be applied to one or more muscles which straighten the arm or open the hand. Training may be progressed by increasing the number of repetitions and speed, adding weight, elevating the work surface and including a number of grasping tasks. There will be no minimum amount of training time or repetitions. Compliance to the intervention will be monitored daily using SMART Arm training record sheets by the treating therapists. Data collected will include time spent training, number of repetitions & amount of supervision for each session. Physiotherapists, Occupational Therapists and Allied health assistants who are trained in use of the SMART Arm device, will administer the training. The amount of supervision required for SMART Arm training will vary, and it is envisioned that many patients will be able to use the device with minimal supervision once set up.
Sponsors
Sally Horsley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
At least 10 days and no more than 6 months post stroke or stroke-like brain injury, unable to extend the affected wrist past neutral or flex the affected shoulder to greater than 90 degrees with the elbow extended.
Exclusion criteria
Language, comprehension or cognitive problems which prevent informed consent and/or participation in the study. Co-existing upper limb problems which directly affect movement. Cannot participate in rehabilitation.
Outcome results
None listed