Enhanced Treadmill Gait Training With Lower Limb Support After Stroke
Enhanced Treadmill Gait Training With Lower Limb Support After Stroke
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
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:

 1. Physical activity recorded over 48 hours using an accelerometer based sensor worn on the
 thigh (ActivPal, PalTechnologies, Glasgow, UK).

 2. Spatiotemporal gait variables (walking speed, cadence, step length, stride length,
 stance duration) during treadmill, overground indoor and overground outdoor walking
 using a combination of motion capture technology (Vicon, Oxford Metrics, Oxford, UK) and
 inertial sensors (Trigno, Delsys, Mass, USA).

 3. Lower limb 3D joint angles during treadmill, overground indoor and overground outdoor
 walking using a combination of motion capture technology (Vicon, Oxford Metrics, Oxford,
 UK) and inertial sensors (Trigno, Delsys, Mass, USA).

 4. Acceptability of the intervention using bespoke satisfaction questionnaires and semi
 structured interviews with the therapists and participants.

 5. Adverse and serious adverse events such as falls, illness, joint/muscle soreness will be
 recorded as part of the routine research governance but also to assess acceptability and
 feasibility.

 6. Community walking ability using a standard questionnaire (Perry, J., et al. (1995).
 "Classification of Walking Handicap in the Stroke Population," Stroke 26(6): 982-989.)
 and a semi structured interview.

 Intervention The core of the intervention will be walking on a self-pacing, single belt,
 treadmill (N-mill, Motekforce link, Amsterdam) in front of a large (65 inch) high definition
 screen (Dell, USA) which will show a virtual reality scene (woodland walk) synchronised with
 the belt speed to provide an immersive walking environment. The treadmill is surrounded by
 six motion capture cameras (VICON, Oxford Metrics, Oxford, UK) which capture the three
 dimensional movement of markers placed on the lower limbs and trunk of the individual. These
 data are used to control the belt speed and provide performance feedback to
 therapists/patients either in real time through visualisation on the screen or afterwards
 when the data are fully processed. Using a Latin square to remove selection bias participants
 will be further allocated to either receive an ankle foot orthosis (AFO group) or functional
 electrical stimulation (FES group), both of which will be used only during the treadmill.
 training. At the initial assessment visit participants will be examined for skin damage or
 impaired circulation in the lower leg and foot which would exclude them from using an AFO or
 FES.

 FES group A dual-channel surface electrical stimulator (NeuroTrac® Rehab, Model number:
 ECS305A) will be used to stimulate four major muscle groups; the ankle dorsiflexors and
 plantarflexors, and the knee flexors and extensors. The FES will be triggered using real time
 data from the motion capture system. The physiotherapist will decide which muscle groups
 should be used to support gait training and the timing and amplitude of the FES administered.
 Participants will be excluded from the FES group if they have any implants in the vicinity of
 the FES sites. These participants will be transferred to the AFO group if they are agreeable.
 Skin integrity will be check at each treatment visit before and after the intervention.
 Should signs of skin trauma present the intervention will discontinued and the participant
 provided with advice and referred to their general practitioner if considered appropriate by
 the physiotherapists.

 AFO group A standard AFO (polypropylene posterior leaf) will be fitted under the guidance of
 the physiotherapist and orthotist. A range of sizes (small, medium, large and extra ) will be
 available (Complete care shop, Lancashire, UK) which will be adjusted using heel raises so
 that the lower leg has an angle of 10-12 degrees to the vertical at the point of mid stance.
 The AFO will be worn during the treadmill walking only. If participants are already using an
 AFO they will continue to use this as before.

 Duration Duration will be determined by the supervising physiotherapist based on the
 participant's tolerance. The aim will be to increase incrementally to a maximum of 20 minutes
 of continuous walking.

 Frequency Frequency will be determined by the supervising physiotherapist based on tolerance
 of the participant and practical issues such as transport. The aim will be to attend three
 times a week.

 The treadmill training (AFO and FES groups) will replace any conventional gait training
 provided by the therapists, however, any unrelated training e.g. Upper limb exercises or
 speech therapy will continue as normal practice.

 Intensity Walking speed will be set at a comfortable pace. Initially this will be 80% of
 their overground indoor walking assessed at week one. Speed will be increased incrementally
 as appropriate and advised by the physiotherapist.
Inclusion Criteria:

 1. Over 18 years old.

 2. Have had a diagnosed stroke.

 3. Onset of stroke between 1 week and 12 months prior to recruitment.

 4. Attending Coathill Hospital (NHS Lanarkshire) for stroke rehabilitation which includes
 gait training.

 5. Have Hemiplegia.

 6. Medically Stable.

 7. Able to follow simple, verbal instructions in English, or in another language if an
 appropriate translator is available.

 8. Able to provide informed consent.

 Exclusion Criteria:

 1. Considered by the GP or NHS clinicians to be unsafe to do mild exercise for the
 duration of time required (about 20 minutes).

 2. Have contracture of the hip, knee or ankle which prevents walking.

 3. Have any skin irritation on the shank.

 4. Have a cardiac pacemaker.

 5. A body mass that exceeds the capacity of the equipment (>100Kg).

 6. Cognitive impairment severe enough to prevent adherence with the protocol (assessed by
 the clinicians responsible for each volunteer).

 7. Walking difficulty before stroke (for example, patients who had history of severe
 spinal stenosis or peripheral vascular diseases)