Clinical trial NCT02637791: A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
Official title: A Low Cost Virtual Reality System for Home Based Rehabilitation of the Upper Limb Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: Stroke
Rehabilitation
Virtual Reality
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Nottingham Trent University
First posted: 2015-12-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke is the third most common cause of mortality and the leading cause of long term disability worldwide with over 900,000 people living in England who have had a stroke. 75% of survivors regain their ability to walk again, however it is estimated that between 55 and 75% fail to regain satisfactory use of their impaired arm. This limits the person's independence, ability to care for themselves and reduces their quality of life. Research indicates that for optimal recovery, high levels of rehabilitation are required yet current provision often fails to meet the required levels of intensity and duration of therapy.

In conjunction with stroke patients, their families and therapists, the team developed a low cost system (the virtual glove) to encourage stroke survivors to practice arm exercises at home. The system tracks infrared light emitting diodes (LEDs) positioned on the fingers turning the hand into a game controller to play games that encourage the movements of reach, grasp and release that underlie activities of daily living.

Before examining its effectiveness, the purpose of the registered study is to determine how feasible a large trial would be in terms of whether sufficient participants could be recruited, whether they would use the glove and whether outcome measures could be collected.

Patients will be recruited if they are aged 18 years or over, are recovering from a stroke, no longer receive any other intensive rehabilitation but still experiencing difficulty using their arm. After baseline measures are collected they will be randomly allocated to either the intervention group or a control group. The intervention group will have the virtual glove and games at home for a period of eight weeks and be advised to use the equipment for 20 minutes, three times a day. The control group will continue to have whatever care they are already receiving but no new interventions.

Outcome measures will be collected at baseline, four weeks and after the equipment has been removed from their home. Outcome measures will include tests of arm function as well participant reports of how often they are using their affected arm and how easy they find activities of daily living. The therapists collecting the outcome measures will not know to which group the participants have been allocated.

Once all outcome measures are collected the two groups will be compared on how much their final outcome measures differ from those collected at baseline.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of stroke, no longer receiving any other intensive rehabilitation (intermediate care, early supported discharge) still experiencing residual upper limb dysfunction.

Exclusion Criteria:

* no detectable movement in the upper limb; premorbid disability in upper limb function; severe symptomatic arm or shoulder pain; severe visual impairments; other neurological illnesses such as head injury or multiple sclerosis; unstable medical condition; psychiatric illness; epilepsy triggered by screen images; cardiac pacemaker; unable to tolerate sitting in a chair for 30 minutes or follow a two stage command or living in a care home.

Primary outcomes:
measure: Wolf Motor Function Test change from baseline at 4 weeks and 8 weeks
timeFrame: Baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: Nine-Hole Peg Test
timeFrame: Baseline, 4 weeks and 8 weeks
Other outcomes:
measure: Motor Activity Log
timeFrame: Baseline, 4 weeks and 8 weeks
measure: Nottingham Extended Activities of Daily Living Scale
timeFrame: Baseline, 4 weeks and 8 weeks
Locations:
Study officials:
affiliation: University of Nottingham
name: Marion Walker, PhD
role: STUDY_DIRECTOR
References: