GASPAR: Gait Adaptation for Stroke Patients With Augmented Reality

Sponsor

Philippe Terrier (Other)

Overall Status

Unknown status

CT.gov ID

NCT02808078

Collaborator

Swiss Heart Foundation (Other)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Traumatic Brain Injury Spinal Cord Injury	Device: Gait training with augmented reality Device: Standard training	N/A

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 Design

Study Type:

Interventional

Anticipated 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 :

Jun 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in walking speed [Pre-intervention (week 0), Post-intervention (week 5)]
Walking speed, measured with the 2-minute walk test

Secondary Outcome Measures

Change in postural control [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 [week 5]
Subjective assessment of the fear of falling. Measured with the adapted Falls Efficacy Scale (FES)
Fear of falling at home [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 [after discharge at 3-4 month]
Short-Form 36 questionnaire (SF-36)
Perception of the intervention [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 [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 [In every gait training sessions, from week 1 to week 4]
Measured with the embedded sensors of the treadmills
Change in step width [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 [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 [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 [In every gait training sessions, from week 1 to week 4]
Measured with the embedded sensors of the treadmills
Change in gait variability [In every gait training sessions, from week 1 to week 4]
Stride-to-stride variability of gait parameters (outcomes 7-12)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.