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Gait Adaptation for Stroke Patients With Augmented Reality

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808078
Acronym
GASPAR
Enrollment
70
Registered
2016-06-21
Start date
2016-06-30
Completion date
2018-12-31
Last updated
2017-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Traumatic Brain Injury, Spinal Cord Injury

Keywords

Instrumented treadmill, Augmented reality, Neurorehabilitation, Gait disorders

Brief summary

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

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.

Interventions

DEVICEGait training with augmented reality

20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality.

20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.

Sponsors

Swiss Heart Foundation
CollaboratorOTHER
Philippe Terrier
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in walking speedPre-intervention (week 0), Post-intervention (week 5)Walking speed, measured with the 2-minute walk test

Secondary

MeasureTime frameDescription
Fear of falling during the hospitalizationweek 5Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)
Fear of falling at homeafter discharge at 3-4 monthSubjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)
Quality of life at homeafter discharge at 3-4 monthShort-Form 36 questionnaire (SF-36)
Perception of the interventionDuring the intervention, week 2 and 4purpose-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 lengthsIn every gait training sessions, from week 1 to week 4Measured with the embedded sensors of the treadmills
Change in postural controlPre-intervention (week 0), Post-intervention (week 5)Capabilities to ensure an optimal postural control. Measured with the Berg Balance test
Change in step widthIn every gait training sessions, from week 1 to week 4Measured with the embedded sensors of the treadmills
Change in left/right asymmetry of step lengthsIn every gait training sessions, from week 1 to week 4Measured with the embedded sensors of the treadmills
Change in left/right asymmetry of step durationsIn every gait training sessions, from week 1 to week 4Measured with the embedded sensors of the treadmills
Changes in stance and swing phasesIn every gait training sessions, from week 1 to week 4Measured with the embedded sensors of the treadmills
Change in gait variabilityIn every gait training sessions, from week 1 to week 4Stride-to-stride variability of gait parameters (outcomes 7-12)
Changes in stride and step durationsIn every gait training sessions, from week 1 to week 4Measured with the embedded sensors of the treadmills

Countries

Switzerland

Contacts

Primary ContactPhilippe Terrier, PhD
Philippe.Terrier@crr-suva.ch+41 27 603 2077
Backup ContactCathia Rossano, MSc
Cathia.Rossano@crr-suva.ch+41 27 603 2073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026