Gait Adaptation Study

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07660601
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Aging

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 31, 2025
Status verified
Jun 2026
Primary completion
May 20, 2028
Completion
Jul 20, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

walking speed [ Time Frame: Baseline and after 4 weeks of training and after 4 weeks of the end of training ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanley Bergen BuildingNewarkNew Jersey07107
Soha Saleh
[email protected]
2014679455

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By research site
Stanley Bergen Building· Newark, NJ

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