Gait Adaptation Study

ConditionAging

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-80

SponsorRutgers, The State University of New Jersey

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: experimental groupExperimental treatment 1 intervention

Group B: control groupActive comparator 1 intervention

Trial outcomes