Gait Adaptation for Stroke Patients With Augmented Reality (GASPAR)
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ClinicalTrials.gov Identifier: NCT02808078 |
Recruitment Status : Unknown
Verified December 2017 by Philippe Terrier, Clinique Romande de Readaptation.
Recruitment status was: Recruiting
First Posted : June 21, 2016
Last Update Posted : December 6, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Traumatic Brain Injury Spinal Cord Injury | Device: Gait training with augmented reality Device: Standard training | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 70 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Visually-guided Gait Training in Paretic Patients During First Rehabilitation: a Randomized Controlled Trial |
Study Start Date : | June 2016 |
Estimated Primary Completion Date : | July 2018 |
Estimated Study Completion Date : | December 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Augmented reality training
Gait training with augmented reality
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Device: Gait training with augmented reality
20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality. |
Active Comparator: Standard training
Gait training without augmented reality
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Device: Standard training
20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality. |
- Change in walking speed [ Time Frame: Pre-intervention (week 0), Post-intervention (week 5) ]Walking speed, measured with the 2-minute walk test
- Change in postural control [ Time Frame: Pre-intervention (week 0), Post-intervention (week 5) ]Capabilities to ensure an optimal postural control. Measured with the Berg Balance test
- Fear of falling during the hospitalization [ Time Frame: week 5 ]Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)
- Fear of falling at home [ Time Frame: after discharge at 3-4 month ]Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)
- Quality of life at home [ Time Frame: after discharge at 3-4 month ]Short-Form 36 questionnaire (SF-36)
- Perception of the intervention [ Time Frame: During the intervention, week 2 and 4 ]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.
- Changes in stride and step lengths [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Measured with the embedded sensors of the treadmills
- Changes in stride and step durations [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Measured with the embedded sensors of the treadmills
- Change in step width [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Measured with the embedded sensors of the treadmills
- Change in left/right asymmetry of step lengths [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Measured with the embedded sensors of the treadmills
- Change in left/right asymmetry of step durations [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Measured with the embedded sensors of the treadmills
- Changes in stance and swing phases [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Measured with the embedded sensors of the treadmills
- Change in gait variability [ Time Frame: In every gait training sessions, from week 1 to week 4 ]Stride-to-stride variability of gait parameters (outcomes 7-12)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02808078
Contact: Philippe Terrier, PhD | +41 27 603 2077 | Philippe.Terrier@crr-suva.ch | |
Contact: Cathia Rossano, MSc | +41 27 603 2073 | Cathia.Rossano@crr-suva.ch |
Switzerland | |
Clinique Romande de Réadaptation | Recruiting |
Sion, Valais, Switzerland, 1951 | |
Contact: Philippe Terrier, PhD Philippe.Terrier@crr-suva.ch | |
Contact: Rossano Cathia, MSc Cathia.Rossano@crr-suva.ch | |
Principal Investigator: Philippe Terrier, PhD |
Principal Investigator: | Philippe Terrier, PhD | Institute for Research in Rehabilitation and Clinique romande de réadaptation |
Responsible Party: | Philippe Terrier, Senior Researcher, Clinique Romande de Readaptation |
ClinicalTrials.gov Identifier: | NCT02808078 |
Other Study ID Numbers: |
CliniqueRR-04 |
First Posted: | June 21, 2016 Key Record Dates |
Last Update Posted: | December 6, 2017 |
Last Verified: | December 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | At the end of the study, final anonymized database will be made available through a specialized online repository |
Instrumented treadmill Augmented reality Neurorehabilitation Gait disorders |
Brain Injuries Spinal Cord Injuries Brain Injuries, Traumatic Wounds and Injuries Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Spinal Cord Diseases |