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Personalized Cognitive Integrated Motor Training Using Virtual Reality to Improve Gait and Balance

NCT06473987 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2024-11-27

No results posted yet for this study

Summary

Problems with walking and balance are common after traumatic brain injury (TBI). Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/augmented reality (AR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training after a brain injury.

The study will evaluate the differences between three intervention groups (n=45 each): 1) personalized cognitive integrated sensorimotor VR/AR training (CMT), 2) traditional dual-task training (CTRL), and 3) standard of care (SOC) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CMT.

Conditions

Interventions

OTHER

Personalized cognitive-sensorimotor VR/AR training

Thinking task integrated walking and balance training program

OTHER

Traditional dual-task training

Walking and balance training similar to standard of care group but will also perform additional thinking tasks during training

OTHER

Standard of Care

Standard walking and balance training

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Kessler Foundation

    lead OTHER

Principal Investigators

  • Kiran K Karunakaran, PhD · Kessler Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2028-07-31
Completion
2028-09-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06473987 on ClinicalTrials.gov