Gait Adaptation for Stroke Patients With Augmented Reality

Study Overview
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Brief Summary
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The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.

Detailed Description
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After a lesion to the central nervous system, many patients suffer from a diminished walking capability. During the first rehabilitation phase, specific cares help the recovery of motor function to offer the best chances of returning to normal walk. For example, the repeated practice of walking exercises facilitates the gain of muscular strength and stimulates motor relearning. However, in patients, who have finished the first rehabilitation phase, it is often observed strong limping, unsteady gait, and a bad management of obstacle clearance. Thus, these individuals fall frequently, with risk of severe injury. The aim of the study is to assess the efficacy of gait training on a treadmill equipped with an augmented reality system. Shapes are displayed onto the treadmill belt with a projector (beamer): the patient adapts his/her gait to the drawing that unfolds in front of him/her. It is possible to train gait symmetry for coordination enhancement or to exercise obstacle clearance and gait agility. Another advantage of this type of treadmill is the capability to continuously analyze gait with integrated sensors and, hence, to give real-time feedback to the patient. Whereas the method seems promising, thorough studies that would confirm its efficacy are lacking. Therefore, the investigators seek to conduct a randomized controlled trial to compare visually-guided gait training with a more classical training method. During four weeks, participants will train, according to their abilities, three to five times a week during 30 minutes on the augmented-reality treadmill. A group of control patients will train at comparable intensity but without the visual guidance of gait. Using the data collected during the training sessions, the investigators will study whether the evolution of locomotor function differs between both groups. Furthermore, several questionnaires will be filled in by the participants to document the self-evaluation of their progress. In the long term, the investigators expect to first improve the efficacy of gait rehabilitation and second to better understand the recovery process of locomotor function during the first months after a stroke.

Official Title
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Visually-guided Gait Training in Paretic Patients During First Rehabilitation: a Randomized Controlled Trial

Conditions
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Stroke, Traumatic Brain Injury, Spinal Cord Injury

Intervention / Treatment
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* Device: Gait training with augmented reality
* Device: Standard training


Participation Criteria
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Eligibility Criteria
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Participants fulfilling all of the following inclusion criteria are eligible for the study: Informed Consent as documented by signature Stroke patients, patients with traumatic brain injury, or patients with spinal cord injury in the acute to sub-acute phase (maximum 40 days after the incident) Need for gait rehabilitation in reason of at least one of the following conditions: Paresis of the lower extremities. Severe balance disorders. No walking at entry due to the neurological injury Ability to walk 2 minutes without or with minimal aid, namely: With the help of one person, or: With walking aid (cane, walker) The presence of any one of the following exclusion criteria will lead to exclusion of the participant: Age < 18 years Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that may threaten the health in case of sustained exercise. Concomitant gait disorders induced by acute to sub-acute musculoskeletal injuries, e.g. fracture of the lower extremities. Severe pre-existent gait disorders that deeply affect walking abilities and gait pattern, either due to musculoskeletal (e.g. severe osteoarthritis) or neurological (e.g. Parkinson's disease) etiologies. Severe non-corrected visual impairment Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Augmented reality training<br>Gait training with augmented reality | Device: Gait training with augmented reality<br>* 20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality.<br>|
| Active Comparator: Standard training<br>Gait training without augmented reality | Device: Standard training<br>* 20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in walking speed | Walking speed, measured with the 2-minute walk test | Pre-intervention (week 0), Post-intervention (week 5) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in postural control | Capabilities to ensure an optimal postural control. Measured with the Berg Balance test | Pre-intervention (week 0), Post-intervention (week 5) | 
| Fear of falling during the hospitalization | Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES) | week 5 | 
| Fear of falling at home | Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES) | after discharge at 3-4 month | 
| Quality of life at home | Short-Form 36 questionnaire (SF-36) | after discharge at 3-4 month | 
| Perception of the intervention | purpose-designed questionnaire that will ask to the participant about their perception of the intervention. The questionnaire will evaluate the satisfaction with intensity, duration and difficulty of the intervention. Other questions will ask about the perceived training effects on walking speed and confidence. | During the intervention, week 2 and 4 | 
| Changes in stride and step lengths | Measured with the embedded sensors of the treadmills | In every gait training sessions, from week 1 to week 4 | 
| Changes in stride and step durations | Measured with the embedded sensors of the treadmills | In every gait training sessions, from week 1 to week 4 | 
| Change in step width | Measured with the embedded sensors of the treadmills | In every gait training sessions, from week 1 to week 4 | 
| Change in left/right asymmetry of step lengths | Measured with the embedded sensors of the treadmills | In every gait training sessions, from week 1 to week 4 | 
| Change in left/right asymmetry of step durations | Measured with the embedded sensors of the treadmills | In every gait training sessions, from week 1 to week 4 | 
| Changes in stance and swing phases | Measured with the embedded sensors of the treadmills | In every gait training sessions, from week 1 to week 4 | 
| Change in gait variability | Stride-to-stride variability of gait parameters (outcomes 7-12) | In every gait training sessions, from week 1 to week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Instrumented treadmill, Augmented reality, Neurorehabilitation, Gait disorders