NCT03045380

Brief Summary

The study was designed to investigate the effect of video games based physical activity training on upper extremity functions, walking, balance and cognitive functions in persons with multiple sclerosis (MS). For this aim, the participants with MS will be divided into three groups: game based physical activity training, conventional rehabilitation, and no intervention groups. The experimental groups will receive therapy sessions once a week for 8 weeks. The no intervention group will receive no intervention, they will be assessed at baseline and after 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
Completed

Started Nov 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

February 3, 2017

Last Update Submit

November 17, 2017

Conditions

Multiple Sclerosis

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 (12)

  • Expanded Disability Status Scale

    Baseline

  • 12-Item Multiple Sclerosis Walking Scale

    Change from Baseline at 8 weeks

  • Timed 25-Foot Walk

    Change from Baseline at 8 weeks

  • Six-Spot Step Test

    Change from Baseline at 8 weeks

  • Five Times Sit to Stand Test

    Change from Baseline at 8 weeks

  • +7 more secondary outcomes

Study Arms (3)

Game based rehabilitation

EXPERIMENTAL

Game based rehabilitation will be administered once a week for 8 weeks.

Other: Game based physical activity training

Conventional rehabilitation

ACTIVE COMPARATOR

Conventional physiotherapy program will be administered once a week for 8 weeks.

Other: Conventional physiotherapy

No intervention

NO INTERVENTION

Waitlist

Interventions

Game based physical activity trainingOTHER

Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with motion sensor (Microsoft) and a 50'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades of the games and types of the games will be changed. A game based physical activity training session takes 30 to 45 minutes. The program will be administered once a week for 8 weeks.

Game based rehabilitation
Conventional physiotherapyOTHER

A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. A conventional physiotherapy session takes 30 to 45 minutes. The program will be administered once a week for 8 weeks.

Conventional rehabilitation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Relapsing-remitting or secondary progressive multiple sclerosis
  • Able to walk at least 100 meters without resting
  • Able to stand for at least half an hour
  • Willingness to participate in the study

You may not qualify if:

  • Neurological disease other than multiple sclerosis
  • A relapse during the study
  • Having undergone orthopedic surgery involving the foot-ankle, knee, hip, spine, affecting balance
  • Serious cognitive or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Therapy and Rehabilitation, Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2017

First Posted

February 7, 2017

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

November 20, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)