Gait Adaptation for Stroke Patients With Augmented Reality

NCT02808078 | Unknown

• 1 other identifier: CliniqueRR-04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Traumatic Brain Injury; Spinal Cord Injury

Keywords

Instrumented treadmill; Augmented reality; Neurorehabilitation; Gait disorders

Outcome Measures

Primary Outcomes (1)

• Change in walking speed

  Walking speed, measured with the 2-minute walk test

  Pre-intervention (week 0), Post-intervention (week 5)

Secondary Outcomes (12)

• Change in postural control

  Pre-intervention (week 0), Post-intervention (week 5)

• Fear of falling during the hospitalization

  week 5

• Fear of falling at home

  after discharge at 3-4 month

• Quality of life at home

  after discharge at 3-4 month

• Perception of the intervention

  During the intervention, week 2 and 4

Study Arms (2)

Augmented reality training

EXPERIMENTAL

Gait training with augmented reality

Device: Gait training with augmented reality

Standard training

ACTIVE COMPARATOR

Gait training without augmented reality

Device: Standard training

Interventions

Gait training with augmented reality DEVICE

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

Augmented reality training

Standard training DEVICE

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

Standard training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philippe Terrier: lead
• Swiss Heart Foundation: collaborator

Study Sites (1)

Clinique Romande de Réadaptation

Sion, Valais, 1951, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 27788679 DERIVED

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Spinal Cord Injuries; Mobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Terrier, PhD

  Institute for Research in Rehabilitation and Clinique romande de réadaptation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Terrier, PhD

CONTACT

+41 27 603 2077; Philippe.Terrier@crr-suva.ch

Cathia Rossano, MSc

CONTACT

+41 27 603 2073; Cathia.Rossano@crr-suva.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 21, 2016
• Study Start: June 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 6, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)