NCT04740060

Brief Summary

Investigate development of an Innovative Instrument on Robot-Aided and Virtual Reality Rehabilitation for Intelligent Physical Training (i.e. gait and stepping) of Individuals post-stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

July 10, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

9 months

First QC Date

February 1, 2021

Last Update Submit

May 16, 2022

Conditions

Keywords

Walking SpeedStep-lengthVirtual RealityExergames

Outcome Measures

Primary Outcomes (3)

  • Walking Speed

    ast walking speed will be measured on the KineAssist and quantified based on the distance covered in one minute as a meter per second.

    Three Minutes

  • Step Length

    Maximum step length will be measured as traveled distance by the foot in centimeters.

    About Five Minutes

  • Intrinsic Motivation

    Intrinsic Motivation Inventory (IMI) will be used as measurement tool after performing each of the three conditions. The IMI consists of 22 questions rating from 1-7 in four subscales (interest/enjoyment, perceived competence, perceived choice, and pressure/tension). For this study, we will only use the Interest/Enjoyment subscale which contains seven questions and is considered as a self-report measure of intrinsic motivation

    About Three Minutes

Secondary Outcomes (6)

  • Apathy Evaluation Scale-Self rated version (AES-S)

    About Five Minutes

  • Activities-Specific Balance Confidence Scale (ABC)

    About Three Minutes

  • Perceived competence,Perceived choice, and Pressure/tension

    About Five Minutes

  • Borg Rating of Perceived Exertion (RPE)

    About Three Seconds

  • Flow State Scale (FSS)

    About Five Minutes

  • +1 more secondary outcomes

Study Arms (3)

Augmented Feedback without Virtual Reality(VR)

EXPERIMENTAL
Other: Augmented Feedback without Virtual Reality(VR

Augmented Feedback with Non-Game based VR

EXPERIMENTAL
Other: Augmented Feedback with Non-Game based VR

Augmented Feedback with Game based VR

EXPERIMENTAL
Other: Augmented Feedback with Game based VR

Interventions

For Walking Speed:One-minute fast walking with visual augmented feedback without VR interface (we ask participants to look at a screen where their walking speed and distance are tracked and increase their speed). For Step Length: Maximum step length with visual augmented feedback without VR interface in which we ask participants to look at a screen where their step length is displayed and attempt to increase their step length up.

Augmented Feedback without Virtual Reality(VR)

For Walking Speed:One-minute fast walking with basic VR interface (we ask participants to look at a screen where their avatar walker representative will be represented in a virtual walking environment and try to make the avatar walk faster). For Step Length: Maximum step length with basic VR interface in which we ask participants to look at their avatar feet in a virtual stepping environment and step with the avatar foot as far as possible.

Augmented Feedback with Non-Game based VR

For Walking Speed: One-minute fast walking with the VR Racing exergame (we ask participants to look at a screen where their avatar walker representative present in a virtual racing environment with other avatar racers and try to beat the avatar racers). For Step Length: Maximum step length with the VR Stepping Exergame (we ask participants to look at their avatar legs and avatar animals in a virtual stepping environment and try to step over the avatar animals without touching the animal.

Augmented Feedback with Game based VR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with hemiparesis in a chronic and stable stroke stage.
  • Able to follow instructions.
  • Able to walk independently without using assistive devices for up to three minutes.

You may not qualify if:

  • Coronary heart disease.
  • Inability to stand and walk independently.
  • Other neurological diseases that impact balance and mobility other than the stroke.
  • Visual impairments that impact their ability to see, focus on and track movable objects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UAB

Birmingham, Alabama, 35294, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

StrokeParesisMobility Limitation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2021

First Posted

February 5, 2021

Study Start

July 10, 2021

Primary Completion

March 30, 2022

Study Completion

May 1, 2022

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

To be determined

Locations