NCT07070388

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

8 months

First QC Date

June 27, 2025

Last Update Submit

July 8, 2025

Conditions

Keywords

RehabilitationUpper LimbRobotMultiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • maximum grip force

    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.

    Baseline (Week 0) and immediately post intervention (Week 4)

  • Maximum isometric wrist force

    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.

    Baseline (Week 0) and immediately post intervention (Week 4)

Secondary Outcomes (3)

  • Wrist tracking task

    Baseline (Week 0) and immediately post intervention (Week 4)

  • wrist range of motion

    Baseline (Week 0) and immediately post intervention (Week 4)

  • Wolf Motor Function Test

    Baseline (Week 0) and immediately post intervention (Week 4)

Study Arms (2)

Indirect training group

EXPERIMENTAL

trained their self-reported less affected upper limb

Device: end-effector robotic training

Direct training group

EXPERIMENTAL

trained their self-reported most affected limb

Device: end-effector robotic training

Interventions

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.

Direct training groupIndirect training group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \- Relapse in the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S3A1, Canada

Location

Related Publications (1)

  • Mannella, K., Albanese, G. A., Ditor, D., Zenzeri, J. & Holmes, M. W. R. Preliminary Evaluation of an Adaptive Robotic Training Program of the Wrist for Persons with Multiple Sclerosis. Appl. Sci. 11, 9239 (2021).

    BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2025

First Posted

July 17, 2025

Study Start

January 1, 2023

Primary Completion

August 31, 2023

Study Completion

June 27, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

De-identified data can be made available upon request from Open-Source Journals.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
June 2025 - June 2028

Locations