Gait Adaptation for Stroke Patients With Augmented Reality (GASPAR)

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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Traumatic Brain Injury; Spinal Cord Injury
• Intervention / Treatment: Device: Gait training with augmented reality; Device: Standard training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Terrier, PhD; Phone Number: +41 27 603 2077; Email: Philippe.Terrier@crr-suva.ch
• Study Contact Backup: Name: Cathia Rossano, MSc; Phone Number: +41 27 603 2073; Email: Cathia.Rossano@crr-suva.ch

Study Locations

• Switzerland
  • Valais
    • Sion, Valais, Switzerland, 1951
      • Recruiting
      • Clinique romande de réadaptation
      • Contact: Philippe Terrier, PhD; Email: Philippe.Terrier@crr-suva.ch
      • Contact: Rossano Cathia, MSc; Email: Cathia.Rossano@crr-suva.ch
      • Principal Investigator: Philippe Terrier, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Augmented reality training; Gait training with augmented reality	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	Device: Standard training; 20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philippe Terrier
• Collaborators: Swiss Heart Foundation
• Investigators: Principal Investigator: Philippe Terrier, PhD, Institute for Research in Rehabilitation and Clinique romande de réadaptation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (ESTIMATE): June 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 5, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Augmented reality; Neurorehabilitation; Gait disorders; Instrumented treadmill
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Stroke; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Spinal Cord Injuries
• Other Study ID Numbers: CliniqueRR-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: At the end of the study, final anonymized database will be made available through a specialized online repository