None listed
Conditions
Brief summary
The research study will trial the Bilateral Upper Limb Trainer incorporating virtual reality (BUiLT + VR) system to establish its effectiveness as therapeutic table-top rehabilitation for the weakened upper limb of subjects who have suffered a stroke. VR is where a computer displays task-based ‘games’ that direct and prompt the user to exercise whilst providing feedback on performance. This will be done by comparing the outcomes of 6 weeks of 4 sessions per week BUiLT + VR therapy in a randomly selected group of sub acute and chronic stroke participants against a matched group of participants who will receive only their usual conventional therapy regime over that time. Assessment using established physical outcome measures and a questionnaire will occur before and after the 6 weeks of therapy and then again 6 months later. After the 6 month assessment the original control group will be offered BUiLT + VR therapy using the same regime in order to ascertain the effects of the therapy in this (now chronic) group. They will be assessed at the completion of that therapy.
Interventions
Volunteers diagnosed with sub-acute or chronic stroke and having upper limb hemiparesis will train using a novel non-robotic and bilateral upper limb training device (BUiLT) coupled with computer games that provide therapeutic exercise. Each participant will train for 6 weeks and undergo 4x45 min sessions per week and the BUiLT training will be in addition to standard therapy. Training will be administered/supervised by specifically trained BUiLT operators and/or physiotherapists.
Sponsors
Industrial Research Ltd (IRL)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Obtained and signed informed consent. (2) Completed Physician/Doctor medical clearance. (3) Diagnosis of first time ischaemic or haemorrhagic cerebrovascular accident, discharged from acute care and not >36 months post stroke with resulting contralateral upper limb weakness. (4) Living within the Christchurch City Council urban zone or having sufficient means to reliably travel to the clinical trial centre
Exclusion criteria
(1) Inability to provide informed consent. (2) Pre-existing neurological conditions or previous brain trauma. (3) History of extra-axial cranial haemorrhage or a history of epidural or sub-dural haemorrhage. (4) Range of movement limitation due to pain, previous trauma or pre-existing conditions. (5) Diagnosed psychological disorder at time of screening that is likely to prevent full participation. (6) Cognitive impairment. (7) Neglect of the affected side. (8) Inability to correctly visualize the trial computer game. (9) Receiving upper limb rehabilitation from another provider in addition to the standard care. (10) Unstable medical or cardiovascular status, malignancy, musculoskeletal condition, immune deficiency, systemic illness, infection, pain, lack of upper limb skin integrity or any other condition that limits upper limb movement and the ability to complete the proposed intervention (other than that permitted). (11) Upper limb lymphodema. (12) Grade 4 or greater for shoulder flexion and elbow flexion power:
Outcome results
None listed