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Completed

NCT Number: NCT07070388

Robotic -Assisted Rehabilitation for Multiple Sclerosis: An Adaptive Approach for Individualized Therapy

Therefore, the purpose of this study was to evaluate four-weeks of an upper limb robotic intervention for persons with Multiple Sclerosis. Participants completed a resistive and adaptive robotic training intervention whereby participants trained three times weekly for four consecutive weeks.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brock University

St. Catharines, Ontario, L2S3A1, Canada

About this study

Nine individuals with Multiple Sclerosis participated and were placed into two groups based that either trained their self-reported less affected limb (indirect training group; N=4) or trained their self-reported more affected limb (direct training group; N=5).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of MS
  • No other neurological diagnosis
  • No injury to the upper limb (i.e., broken bones)

Exclusion criteria

  • Relapse in the past 6 months

Treatment and study plan

end-effector robotic training

Device

For the robotic training sessions, a haptic wrist robot known as the Wristbot was used (ReWing, Genova, Italy). The training protocol consisted of an eccentric contraction-based exercise. Participants trained 3x per week for 4 consecutive weeks for approximately 25-mins per session.

Primary outcomes

  1. maximum grip force

    Time frame: Baseline (Week 0) and immediately post intervention (Week 4)

    Participants were asked to complete one trial of a maximum grip test (Baseline Evaluation Instruments). Held with a straight arm, 45° abduction by the side and hand/wrist neutral, participants were asked to squeeze the handle as hard as possible for 3 seconds and grip force (Newton) was recorded.

  2. Maximum isometric wrist force

    Time frame: Baseline (Week 0) and immediately post intervention (Week 4)

    the participant's arm was fully extended and rested on the table, and participants were instructed to exert force at the wrist joint (F/E, RD/UD) as hard as they could against the stationary load cell that rested on the metacarpophalangeal joints (Model: BG 500, Mark-10 Corporation, New York, USA). Two maximal exertions were completed and the largest value was recorded.

Secondary outcomes

  1. Wrist tracking task

    Time frame: Baseline (Week 0) and immediately post intervention (Week 4)

    Participants were positioned in the same position as the training. By moving the end-effector with their wrist, participants tracked a moving icon around a Lissajous-curve. Participants were instructed to follow the icon as closely as possible. The target icon moved at a velocity of 20 °/s and 5 total laps were completed. Tracking and figural error were calculated as measures of performance.

  2. wrist range of motion

    Time frame: Baseline (Week 0) and immediately post intervention (Week 4)

    • Participants grasped the end-effector as target icons appeared on the monitor in front of them, participants were then asked to match the icon to the best of their abilities. When the user was at their maximal end-point range, the data was stored and recorded by the robotic device. This assessment consisted of two repetitions in each direction F/E, RD/UD.

  3. Wolf Motor Function Test

    Time frame: Baseline (Week 0) and immediately post intervention (Week 4)

    functional clinical assessment of the upper limb

Sponsors and collaborators

Lead sponsor

Michael Holmes

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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