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| Name | Class |
|---|---|
| Swiss Heart Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented reality training | Experimental | Gait training with augmented reality |
|
| Standard training | Active Comparator | Gait training without augmented reality |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait training with augmented reality | Device | 20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality. |
|
| 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) |
| 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 |
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Participants fulfilling all of the following inclusion criteria are eligible for the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Terrier, PhD | Contact | +41 27 603 2077 | Philippe.Terrier@crr-suva.ch | |
| Cathia Rossano, MSc | Contact | +41 27 603 2073 | Cathia.Rossano@crr-suva.ch |
| Name | Affiliation | Role |
|---|---|---|
| Philippe Terrier, PhD | Institute for Research in Rehabilitation and Clinique romande de réadaptation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Romande de Réadaptation | Recruiting | Sion | Valais | 1951 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27788679 | Derived | Rossano C, Terrier P. Visually-guided gait training in paretic patients during the first rehabilitation phase: study protocol for a randomized controlled trial. Trials. 2016 Oct 27;17(1):523. doi: 10.1186/s13063-016-1630-8. |
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At the end of the study, final anonymized database will be made available through a specialized online repository
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| D013119 | Spinal Cord Injuries |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Standard training | Device | 20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality. |
|
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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D013118 | Spinal Cord Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |