Recruiting

Functional Recovery

Sponsor:

Kessler Foundation

Code:

NCT06197685

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)

Stretching and Toning (S/T)

Study Details

Brief summary:

The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.

Conditions

Multiple Sclerosis

Study ID

NCT06197685

Start date

Feb 12, 2024

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be within the ages of 18 and 70 years of age
  • Speak English as their primary language
  • Confirmed MS diagnosis by a neurologist
  • Be relapse and steroid-free for at least 30 days
  • Mild-to-moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS)
  • Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ)
  • Right handedness

Exclusion Criteria:

  • History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
  • Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Currently use medications that may impact cognition (ex: steroids, benzodiazepines)
  • Currently pregnant
  • Contraindication for MRI (metal or electronic devices in the body that are not considered MRI safe)
  • Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)

Study Design

Enrollment

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)

In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning/memory; IDEAL) three days per week over a 12 week period. For seven weeks, participants will only complete IDEAL. For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.

experimental: Cognitive Rehabilitation + Stretching and Toning

In the cognitive rehabilitation and stretching and toning (S/T) exercise condition, participants will complete 12 weeks of supervised S/T activities 3 days per week over the 12 week period. For seven weeks, participants will only complete S/T. During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.

Interventions

The Kessler Foundation modified Story Memory Technique® (KF-mSMT®)

KF-mSMT is a memory retraining technique that consists of two-related skills: (1) imagery and (2) context/organization. The proposed KF-mSMT intervention includes 10 total sessions with 2 sessions per week for 5 weeks. Each session will last 45-60 minutes.

Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL)

The AET condition includes 12 weeks of supervised, progressive, moderate intensity cycle ergometry. The AET will include semi-immersive, interactive VR such the cycling speed on the bike will translate directly to perceived speed through the virtual environment.

Stretching and Toning (S/T)

The S/T condition will include 12 weeks of supervised S/T activities that target the head/neck. shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.

Primary outcome measure

  • Change in objective new learning and memory (NLM). [ Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) ]
  • Change in everyday memory [ Time Frame: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention) ]

Central Contacts and Locations

Central contacts

Carly Wender, PhD

(973) 324-8388cwender@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Carly Wender, PhD

9732436984cwender@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Multiple Sclerosis
  • Aerobic exercise
  • Virtual Reality
  • Leg cycling
  • Mobility disability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-08-05.