Recruiting
Early Phase 1

Rehabilitation Training

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT07660601

Conditions

Aging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Gait Adaptation Training

Basic Physical Training

Study Details

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

Study ID

NCT07660601

Start date

Jan 31, 2025

Status verified date

Jun, 2026

Completion date

Jul 20, 2028

Anticipated

Primary completion date

May 20, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria Psychiatric disorders, only those requiring treatment because the medications may affect brain activation Neurological disorder that may affect cognition, balance, and/or physical wellness such as brain injury, or stroke.

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: experimental group

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

active comparator: control group

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

Interventions

Gait Adaptation Training

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.

Basic Physical Training

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.

Primary outcome measure

  • walking speed [ Time Frame: Baseline and after 4 weeks of training and after 4 weeks of the end of training ]
  • Dynamic Gait Index (DGI) [ Time Frame: Baseline and after 4 weeks of training and after 4 weeks of the end of training ]
  • Resting-state brain connectivity [ Time Frame: Baseline and after 4 weeks of training and after 4 weeks of the end of training ]
  • brain-muscle coherence [ Time Frame: Baseline and after 4 weeks of training and after 4 weeks of the end of training ]

Central Contacts and Locations

Central contacts

Soha Saleh, PhD

9739720472soha.saleh@rutgers.edu

Emily Peters, MS

petersen@shp.rutgers.edu

Locations

Stanley Bergen Building

Recruiting

Newark, New Jersey, United States, 07107

Contacts

Soha Saleh

2014679455soha.saleh@rutgers.edu

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-06-22.