Exergaming in Persons With Multiple Sclerosis With Restless Legs Syndrome

NCT03878810 | Completed

• 1 other identifier: 2019/01-138
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

In this studly, the effects of an 8-week videogame-based physical activity training in persons with multiple sclerosis will be investigated.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• International Restless Legs Syndrome Study Group rating scale for restless legs syndrome

  The International Restless Legs Syndrome Study Group rating scale for restless legs syndrome is used to assess severity of the restless legs syndrome symptoms. It consists of 10 items scored by 0 to 4. Possible scores range from 0 to 40. Higher scores indicate higher severity.

  Change from Baseline at 8 and 16 weeks

Secondary Outcomes (11)

• Timed 25-Foot Walk

  Change from Baseline at 8 and 16 weeks

• 12-Item Multiple sclerosis walking scale

  Change from Baseline at 8 and 16 weeks

• Modified Fatigue Impact Scale

  Change from Baseline at 8 and 16 weeks

• Timed Up and Go test

  Change from Baseline at 8 and 16 weeks

• 6-Minute Walk Test

  Change from Baseline at 8 and 16 weeks

Other Outcomes (2)

• Restless Legs Syndrome Diagnostic Criteria

  At Baseline

• Expanded Disability Status Scale

  At Baseline

Study Arms (4)

Exergaming, restless legs syndrome (+)

EXPERIMENTAL

A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.

Behavioral: Exergaming

Exergaming, restless legs syndrome (-)

EXPERIMENTAL

A video game-based physical activity training will be applied under a physiotherapist supervision for 2 days/week for 8 weeks.

Behavioral: Exergaming

Control, restless legs syndrome (+)

NO INTERVENTION

No specific intervention.

Control, restless legs syndrome (-)

NO INTERVENTION

No specific intervention.

Interventions

Exergaming BEHAVIORAL

A video game-based physical activity training applied using a commercial game console.

Exergaming, restless legs syndrome (+); Exergaming, restless legs syndrome (-)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A relapsing-remitting or secondary progressive type of multiple sclerosis,
• Being able to walk at least 100 meters without resting,
• Being able to stably stand for half an hour,
• To be willing to participate in the study.

You may not qualify if:

• Another neurological disorder,
• Relapse during the study period,
• Orthopedic surgery history including the ankle-foot, knee, hip, or spine, affecting balance,
• Diagnosed severe cognitive and/or psychiatric impairment

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

MS Outpatient Clinic, Dokuz Eylul University Hospital

Izmir, 35430, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exergaming

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Serkan Ozakbas, MD

  Izmir Katip Celebi University

  STUDY DIRECTOR

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: Principal Investigator

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: March 18, 2019
• Study Start: March 29, 2019
• Primary Completion: September 15, 2021
• Study Completion: December 15, 2021
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

TU (1)