The Design and Testing of a Targeted, Treadmill Based Training Program for Post-Stroke Gait Rehabilitation, Through Co-Production With Users; Incorporating Visual Flow, and Functional Electrical Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Strathclyde
- Enrollment
- 21
- Locations
- 2
- Primary Endpoint
- Participant compliance with the intervention
Study Overview
Brief Summary
This series of single case studies aims to test the feasibility and acceptability of an enhanced treadmill system for the recovery of gait function in stroke survivors. Forty adult participants who have had a stroke in the past year that resulted in impaired gait function and are attending a local hospital for gait training, will be recruited. Participants will be asked to attend a rehabilitation clinic for seven weeks, three times a week where they will receive enhanced treadmill training supervised by a physiotherapist. Assessment sessions will take place in week 1, weeks 5 and 8, and after 3 months. Outcome measures recorded during assessment sessions will include gait variables (e.g. speed, cadence, step length and joint kinematics) measured overground and on the treadmill using motion capture technology and outside using body worn sensors (inertial motion unit). Participants will complete a questionnaire on their community walking habits and asked to wear a physical activity monitor for 48 hours to record stepping time.
The basic intervention will comprise of walking on a treadmill capable of adjusting its speed to match that of the user (using feedback from the motion capture system) and a large television screen showing a virtual reality scene (woodland walking) with visual perturbations (virtual obstacle avoidance). In addition participants will be divided equally and randomly (Latin square) to either wear an ankle foot orthosis (AFO group) or functional electrical stimulation (FES group) while walking on the treadmill but not provided for home use. Training sessions will last up to a max of 20 minutes, will be supervised by a physiotherapist and participants will wear a safety harness to remove any risk of trip falls. Any adverse event such as muscle/joint pain, illness or a fall at home will be recorded, participants and physiotherapists will also be asked for feedback on their experience with the treadmill system using questionnaires and semi-structured interviews
Detailed Description
Design Series of single case studies investigating feasibility and acceptability of an enhanced treadmill training system incorporating self pacing, virtual reality and biomechanical support with either an ankle foot orthosis (AFO) or functional electrical stimulation (FES) which will be decided using a Latin square.
Participants Individuals referred to rehabilitation services due to impaired walking function resulting from a stroke in the past 12 months and who are medically stable, will be invited to participate.
Target sample size = 40. Eligible participants will be approached about participation by a clinical trials nurse who will allow at least 48 hours for consideration before giving consent. The percentage of eligible people invited to participate who then agree to participate will be noted as the recruitment rate.
Outcome measures Following informed consent, participants will be asked to attend a physiotherapy gym at a local hospital for a total of eight consecutive weeks, three times a week with a follow assessment 3 months later.
Outcome measures will be recorded at weeks 1, 5, 8 and 20. These will include:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
The primary gait measure (number of daily steps in teh community) will be collected by an independent assessor.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over 18 years old.
- •Have had a diagnosed stroke.
- •Onset of stroke between 1 week and 12 months prior to recruitment.
- •Attending Coathill Hospital (NHS Lanarkshire) for stroke rehabilitation which includes gait training.
- •Have Hemiplegia.
- •Medically Stable.
- •Able to follow simple, verbal instructions in English, or in another language if an appropriate translator is available.
- •Able to provide informed consent.
Exclusion Criteria
- •Considered by the GP or NHS clinicians to be unsafe to do mild exercise for the duration of time required (about 20 minutes).
- •Have contracture of the hip, knee or ankle which prevents walking.
- •Have any skin irritation on the shank.
- •Have a cardiac pacemaker.
- •A body mass that exceeds the capacity of the equipment (>100Kg).
- •Cognitive impairment severe enough to prevent adherence with the protocol (assessed by the clinicians responsible for each volunteer).
- •Walking difficulty before stroke (for example, patients who had history of severe spinal stenosis or peripheral vascular diseases)
Outcomes
Primary Outcomes
Participant compliance with the intervention
Time Frame: 12 months
Proportion of participants attending 60% of training sessions.
Secondary Outcomes
- Gait performance(12 months)
- Participants satisfaction with the intervention and overall research experience(12 months)
- Participant satisfaction with the enhanced treadmill training.(12 months)
- Community walking ability(12 months)
- Physical activity behaviour(12 months)
Investigators
Andrew Kerr
Principal Investigator
University of Strathclyde