NCT05073731

Brief Summary

In this studly, the effects of an 8-week telerehabilitation-based upper extremity training in persons with multiple sclerosis will be investigated.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 25, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

September 25, 2021

Last Update Submit

May 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Nine-Hole Peg Test

    The Nine-Hole Peg Test measures finger dexterity.

    Change from Baseline at 8 weeks

Secondary Outcomes (9)

  • Expanded Disability Status Scale

    Baseline

  • Jamar Hand Dynamometer

    Change from Baseline at 8 weeks

  • Arm Function in Multiple Sclerosis Questionnaire

    Change from Baseline at 8 weeks

  • Preference-based Multiple Sclerosis Index

    Change from Baseline at 8 weeks

  • The Modified Fatigue Impact Scale - 5

    Change from Baseline at 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Synchronized Telerehabilitation

EXPERIMENTAL

Physical activity training aiming to increase hand/arm function and fine motor function will be applied via videoconference for 8 weeks, 2 days a week, in 45-60 minute sessions.

Other: Telerehabilitation-based Upper Extremity Training

Asynchronous Telerehabilitation

ACTIVE COMPARATOR

Exercise videos and exercise tracking form will be sent.

Other: Telerehabilitation-based Upper Extremity Training

Interventions

Telerehabilitation has been defined as "the delivery of rehabilitation services through information and communication technologies". Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training.

Asynchronous TelerehabilitationSynchronized Telerehabilitation

Eligibility Criteria

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

You may qualify if:

  • Having a definitive diagnosis of MS according to the 2017 McDonald criteria
  • Being over 18 years old
  • Having answered yes to the question "Do you experience restriction in your hand-arm function and fine motor skills while performing your functional activities in daily life, and does this restriction limit your activities?"
  • To have sufficient computer knowledge or to have a relative who can help in this regard to participate in the study for people with MS in the telerehabilitation group
  • Having a computer and active internet connection at home for individuals with MS in the telerehabilitation group
  • To be willing to participate in the study.

You may not qualify if:

  • Having a neurological disease other than MS
  • Having a relapse 30 days before or during the study
  • Having an orthopedic problem that may affect the function of the upper extremity
  • Cognitive disability at a level that hinders assessment and treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Therapy and Rehabilitation, Dokuz Eylül University

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Serkan Ozakbas, MD

    MS Outpatient Clinic, Dokuz Eylul University Hospital

    STUDY DIRECTOR

Central Study Contacts

Turhan Kahraman, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 11, 2021

Study Start

December 15, 2021

Primary Completion

September 30, 2022

Study Completion

October 28, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations