NCT05571631

Brief Summary

This study will investigate the effects of a 12-week arm ergometer exercise and balance training on upper extremity function in persons with multiple sclerosis.

Trial Health

35
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 Oct 2022

Typical duration for not_applicable multiple-sclerosis

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

October 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

1.9 years

First QC Date

October 5, 2022

Last Update Submit

October 5, 2022

Conditions

Keywords

multiple sclerosisupper extremitybalancerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Nine-Hole Peg Test

    The Nine-Hole Peg Test measures finger dexterity.

    Change from Baseline at 12 weeks

Secondary Outcomes (9)

  • Expanded Disability Status Scale

    Baseline

  • Jamar Hand Dynamometer

    Change from Baseline at 12 weeks

  • Arm Function in Multiple Sclerosis Questionnaire

    Change from Baseline at 12 weeks

  • Preference-based Multiple Sclerosis Index

    Change from Baseline at 12 weeks

  • Estimated VO2 Max

    Change from Baseline at 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Arm ergometer-balance training

EXPERIMENTAL

Combination of arm ergometer exercise and balance training

Other: exercise

arm ergometer

EXPERIMENTAL

Only arm ergometer exercise training

Other: exercise

Interventions

Arm ergometer will aplied as an aerobic exercise. Combination of balance training and arm ergometer exerise program will applied.

Arm ergometer-balance trainingarm ergometer

Eligibility Criteria

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

You may qualify if:

  • A relapsing-remitting or secondary progressive type of multiple sclerosis,
  • To be willing to participate in the study.

You may not qualify if:

  • Another neurological disorder,
  • Orthopedic surgery history including the elbow, wrist, shoulder, ankle-foot, knee, hip or spine, affecting balance and upper extremity functions,
  • Diagnosed severe cognitive and/or psychiatric impairment,
  • Having congestive heart failure, coronary, cerebrovascular, and pulmonary disease such as COPD
  • Having cardiac disease such as hypertension that would be a contraindication to exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Asiye Tuba Ozdogar, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 7, 2022

Study Start

October 15, 2022

Primary Completion

September 15, 2024

Study Completion

November 15, 2024

Last Updated

October 7, 2022

Record last verified: 2022-10