Gait Adaptation Study

NCT07660601 | Recruiting Early Phase 1

• 1 other identifier: Pro2024001093
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study proposes a clinical trial to target treatment of sensorimotor and cognitive deficits in persons with Multiple Sclerosis (pwMS). The proposal has the potential to promote neuroplasticity and induce re-normalization in brain to muscle (cortico-muscular) connectivity (BMC) and within brain connectivity via an integrative training approach. Preliminary data and published work are available to inform specific aspects of the proposed trial, along with the general rationale for exploring the suggested rehabilitation approach. However, there is a gap in research on the effects of training that uses the proposed approach via a clinical trial (of any phase) in pwMS to support the rationale for exploring the suggested rehabilitation training approach. Moreover, there is no pilot data on the training itself in the same population. This study will examine the behavioral deficits and neural characteristics in children with MS and two other related conditions (Myelin Oligodendrocyte Glycoprotein (MOG) and Nueromyelitis Optica Spectrum Disorder (NMOSD)) to understand if they would benefit from rehabilitation training conditions tested in aims 1 and 2. The overall long term goal is to improve rehabilitation training conditions for both adults and children with MS.

Conditions

Aging

Keywords

cognition; mobility; impairment; electrophysiology; gait; gait adaptation; daily living

Outcome Measures

Primary Outcomes (4)

• walking speed

  25ftWT

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

• Dynamic Gait Index (DGI)

  assessments of gait

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

• Resting-state brain connectivity

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

• brain-muscle coherence

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

Secondary Outcomes (3)

• 6 min walking test

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

• Cardiovascular measure

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

• congition

  Baseline and after 4 weeks of training and after 4 weeks of the end of training

Study Arms (2)

experimental group

EXPERIMENTAL

A group of persons with MS will be randomized to receive GAT or BPT interventions

Behavioral: Gait Adaptation Training

control group

ACTIVE COMPARATOR

Persons with MS will enroll in training that involves basic physical training.

Behavioral: Basic Physical Training

Interventions

Gait Adaptation Training BEHAVIORAL

GAT Intervention Condition: Participants will be trained for 12 sessions (4 weeks, 3 sessions per week) in a supervised paradigm that involves navigating an MR environment. This duration of GAT is consistent with research in neurological populations reporting mobility and cognitive improvements. The MR environment, built in Unity engine using the Mixed Reality Toolkit, will include externally cued targets that will appear as virtual objects. Participants are expected to perform precise real word activities like stacking books on shelves, picking up objects, etc (see Figure 1 in section 10). Microsoft HoloLens 2 MR goggles will be used to project these targets onto the real-world environment. For the current proposal, a library of 5 training applications during walking will be standardized across participants. Figure 1 shows an example of two applications.

experimental group

Basic Physical Training BEHAVIORAL

BPT Condition: Training will take place with the same training dosage (duration) as the GAT condition; however, there will be no environmental or cognitive challenges applied. To control for upper extremity activities in the GAT training conditions (stacking objects, grasping, etc), BPT will include 10 minutes of practicing single upper extremity tasks while seated (reaching, grasping), followed by performing 30 minutes of single walking training in the gait lab without any cognitive demands.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 yrs Clinically definite MS diagnosis Ability to attend to computer screen and follow instructions in English which will be assessed by MiniMental test requiring a participant to score \>24 (out of 30 max score) Right-handed as determined by research diagnostic criteria of the Edinburgh Handedness Inventory (Oldfield 1971) Self report of normal or corrected-to-normal vision

You may not qualify if:

• Orthopedic injuries or neuromuscular disorder that may affect balance or mobility Engagement in other cognitive or physical training program while enrolled in this study Ongoing relapse (new or returning neurological symptoms) or steroid treatment during the 30 days preceding enrollment

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Stanley Bergen Building

Newark, New Jersey, 07107, United States

RECRUITING

Study Officials

• Soha Saleh, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soha Saleh, PhD

CONTACT

9739720472; soha.saleh@rutgers.edu

Emily Peters, MS

CONTACT

petersen@shp.rutgers.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessors will be blinded to which group the subject is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: single-blind, 2-arm RCT that compares the effects of a 12-session GAT intervention with an active control condition on functional and neuroimaging outcomes in 30 participant

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: June 22, 2026
• Study Start: January 31, 2025
• Primary Completion (Estimated): May 20, 2028
• Study Completion (Estimated): July 20, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)