Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients

Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).

Methods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.

Patients were followed up for 2 years after 5 weeks of intensive care. Tests are performed every six months.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive
• Intervention / Treatment: Other: Training groupe; Other: PNF; Other: Spinning grp; Other: Balance

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Somogy
    • Kaposvár, Somogy, Hungary, 7400
      • Somogy Megyei Kaposi Mor Oktato Korhaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Multiple Sclerosis
• instability problem

Exclusion Criteria:

• Severe heart problems, severe demeanor, alcoholism, drug problems

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Controll; No intervention
Experimental: Training grp; Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training	Other: Training groupe; Using virtual training
Experimental: PNF; 2 years long, You have only treated patients with the PNF technique.	Other: PNF; PNF technique was used
Experimental: Spinning group; Patients developed endurance for 2 years. They worked using a spinning bike.	Other: Spinning grp; They only worked with spinning bikes.
Experimental: Balance; Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance	Other: Balance; Balance development was done

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postural instability	Body sway (mm) (Posturography test)	2 years
EQ-5D quality of life	EQ-5D (EQ-5D was first introduced in 1990 by the EuroQol Group, The EQ-5D questionnaire is made up for two components; health state description and evaluation)	2 years
balance test	Berg Balance test (The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks, 41-56 = low fall risk, 21-40 = medium fall risk, 0 -20 = high fall risk )	2 years
mobility test	Six minutes walk test (6MWT) (m) (The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway)	2 years
depression scale	Beck Depression scale (The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, 0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression)	2 years
MSIS-29	Multiple Sclerosis Questionnaire	2 years

Collaborators and Investigators

• Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2018
• Primary Completion (Actual): April 6, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 10, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: multiple sclerosis; neurorehabilitation; balance; posture
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
• Other Study ID Numbers: IKEB2020/08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No