None listed
Conditions
Brief summary
The aim of this project is to demonstrate the effectiveness of using visual feedback to increase toe clearance during walking in people with stroke. This new intervention has the potential to improve walking safety and reduce the risk of trips and falls. One important gait variable in these types of trips is minimum toe clearance (MTC). Reduced MTC can increase the risk of tripping. 150 participants will be required to attend 16 sessions (two baseline assessments (one clinical assessment conducted by a Physiotherapist and practice walking on the treadmill, the other is biomechanical assessment to determine MTC), 10 gait training only, and 4 post-training assessments (one after completing the final training, and then 1 month, 3 months and 6 months post-training follow up session). Half of the participants (n=75) will be randomly assigned to an Experimental group who will receive treadmill-based gait training with toe clearance feedback and half will comprise a Control group who will undertake assessment and training trials exactly as the Experimental group but will NOT receive the corrective real time feedback. The ten training sessions will occur over a 5-6 week period, with at least one rest day between sessions. Six assessment sessions will be about 90 minutes duration. The training sessions will take approximately 60 minutes. At all sessions, participants will be required to walk on a treadmill for up to 10 minutes. They will wear a safety harness which will prevent them from falling. Participants will also have markers placed on their lower limbs, and a special camera (Optotrak) will record the movement of these markers while participants walk. Data will be recorded during assessment sessions, and additional clinical data will also be obtained. Participants will be asked some questions about their risk of falls. During the training sessions, data from markers will provide ‘real time’ feedback to Experimental participants about their affected leg toe clearance during the swing phase of walking. Using this information, participants will be asked to modify their walking pattern to match a “target” increased toe clearance. Feedback will be provided continuously for the first 6 sessions and then progressively reduced (faded) across the last 4 sessions.
Interventions
Eligible participants who have given informed consent will be randomly assigned to one of two gait training groups: no-feedback (control), and feedback (experimental group). Clinical and Demographic Assessment (all participants): Demographic and anthropometric data will be collected at initial assessment; including age, gender, body mass, standing height, lesion site, date of stroke and medical history. Clinical tests will be conducted at initial assessment and the 4 post training retention tests to provide information about specific impairments, and level of function. Clinical tests will be conducted by an experienced physiotherapist who is blind to group allocation: Baseline gait assessment (all participants) - Conducted at Victoria University biomechanics laboratory and at Austin Repatriation Hospital within the physiotherapy department. Gait assessments will include both treadmill walking and overground walking to establish pre-training (Baseline) performance and determine the Minimum Toe Clearance (MTC) feedback criterion for the experimental group. Training and testing will be undertaken in comfortable walking shoes. Participants will wear the same shoes throughout. Participants will also wear a safety harness and will walk at their preferred walking speed (calculated during treadmill familiarisation during visit 1 (session 1). Markers will be placed on the shoe, lower limb and the trunk. Optotrak 3D motion capture system will be used to determine the trajectory of the markers and Visual 3D software will be used to determine Minimum Toe Clearance event for each walking stride and calculate the vertical displacement between the ground (treadmill belt) and the forefoot at this event (MTC). The mean and standard deviation of MTC will be calculated. Once baseline assessment has been completed, all participants will complete 10 gait training sessions of treadmill walking over 5-6 weeks, with MTC target information presented in real-time for the experimental group. Participants will walk for up to 10 minutes during gait training. A single marker will be placed on the forefoot area of the affected limb to calculate toe clearance in real-time. Participants will be asked to modify their gait pattern to match a required “target” criterion (increased MTC). Baseline MTC data from the affected limb will be used to set the training target at mean baseline MTC plus one standard deviation. The training target MTC will be projected on a screen in front of the participant with parallel lines above and below indicating a target band. Participants will view their toe movement and minimum clearance in real-time and will be required to modify their affected limb motion to match the “target” toe clearance. Borg rating of perceived exertion will be recorded after each session. . The first 6 sessions will involve continuous visual biofeedback. Duration of biofeedback will then be progressively reduced (faded) across the remaining four sessions. Gait assessment will again be conducted after the final training session, one at 1-month post training and two relatively longer-term (3 months and 6 months). In retention conditions, participants will be asked to reproduce the movement criterion presented during the gait training sessions but no feedback will be provided.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants will be adults over 18 years who have sustained a stroke at least 6 months previously, are able to walk 50 metres independently and cognitively capable of providing informed consent.
Exclusion criteria
1. Require an ankle foot orthosis, electrical stimulation or other assistance to dorsiflexion. 2. Are pregnant. 3. Have (in addition to stroke) additional neurological, orthopaedic, cardiac, respiratory or other medical conditions that may impact on their ability to walk on a treadmill. 4. Have multiple strokes. Participants will still be eligible if incidental lesions are identified on imaging, so long as there is no clinical history of previous stroke. 5. Are over 158 kg (weight limit of the harness system). 6. Have visual problems or visual-spatial neglect, as the protocol relies on visual biofeedback. People who score < 22 on the star cancellation test will be excluded.