Gait Adaptation for Stroke Patients With Augmented Reality

NCT ID: NCT02808078

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-12-31

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.

Conditions

Stroke; Traumatic Brain Injury; Spinal Cord Injury

Keywords

Instrumented treadmill; Augmented reality; Neurorehabilitation; Gait disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Augmented reality training

Gait training with augmented reality

Group Type: EXPERIMENTAL

Gait training with augmented reality

Intervention Type: DEVICE

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

Standard training

Gait training without augmented reality

Group Type: ACTIVE_COMPARATOR

Standard training

Intervention Type: DEVICE

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

Interventions

Gait training with augmented reality

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

Intervention Type: DEVICE

Standard training

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Heart Foundation

OTHER

Sponsor Role: collaborator

Philippe Terrier

NETWORK

Sponsor Role: lead

Responsible Party

Philippe Terrier

Senior Researcher

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Philippe Terrier, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute for Research in Rehabilitation and Clinique romande de réadaptation

Locations

Clinique Romande de Réadaptation

Sion, Valais, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Philippe Terrier, PhD

Role: CONTACT

Phone: +41 27 603 2077

Email: Philippe.Terrier@crr-suva.ch

Cathia Rossano, MSc

Role: CONTACT

Phone: +41 27 603 2073

Email: Cathia.Rossano@crr-suva.ch

Facility Contacts

Philippe Terrier, PhD

Role: primary

Rossano Cathia, MSc

Role: backup

References

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.

Reference Type: DERIVED

PMID: 27788679 (View on PubMed)

Other Identifiers

CliniqueRR-04

Identifier Type: -

Identifier Source: org_study_id