Gait Adaptation for Stroke Patients With Augmented Reality (GASPAR)

• ClinicalTrials.gov Identifier: NCT02808078
• Recruitment Status: Unknown
• First Posted: June 21, 2016
• Last Update Posted: December 6, 2017
• Sponsor: Philippe Terrier
• Collaborator: Swiss Heart Foundation
• Information provided by (Responsible Party): Philippe Terrier, Clinique Romande de Readaptation

Tracking Information

• First Submitted Date: June 14, 2016
• First Posted Date: June 21, 2016
• Last Update Posted Date: December 6, 2017
• Study Start Date: June 2016
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 16, 2016)

Change in walking speed [ Time Frame: Pre-intervention (week 0), Post-intervention (week 5) ]

Walking speed, measured with the 2-minute walk test

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 16, 2016)

• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gait Adaptation for Stroke Patients With Augmented Reality
• Official Title: Visually-guided Gait Training in Paretic Patients During First Rehabilitation: a Randomized Controlled Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Stroke
• Traumatic Brain Injury
• Spinal Cord Injury

Intervention

• Device: Gait training with augmented reality
  20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality.
• Device: Standard training
  20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.

Study Arms

• Experimental: Augmented reality training
  Gait training with augmented reality
  Intervention: Device: Gait training with augmented reality
• Active Comparator: Standard training
  Gait training without augmented reality
  Intervention: Device: Standard training

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: June 16, 2016): 70
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2018
• Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02808078
• Other Study ID Numbers: CliniqueRR-04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

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

• Current Responsible Party: Philippe Terrier, Clinique Romande de Readaptation
• Original Responsible Party: Same as current
• Current Study Sponsor: Philippe Terrier
• Original Study Sponsor: Same as current
• Collaborators: Swiss Heart Foundation

Investigators

• Principal Investigator: Philippe Terrier, PhD; Institute for Research in Rehabilitation and Clinique romande de réadaptation

• PRS Account: Clinique Romande de Readaptation
• Verification Date: December 2017