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

Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04550650
Collaborator
(none)
4
1
5
28.9
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Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Training groupe
  • Other: PNF
  • Other: Spinning grp
  • Other: Balance
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Actual Study Start Date :
Apr 6, 2018
Actual Primary Completion Date :
Apr 6, 2020
Actual Study Completion Date :
Sep 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Postural instability [2 years]

    Body sway (mm) (Posturography test)

  2. EQ-5D quality of life [2 years]

    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)

  3. balance test [2 years]

    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 )

  4. mobility test [2 years]

    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)

  5. depression scale [2 years]

    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)

  6. MSIS-29 [2 years]

    Multiple Sclerosis Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Multiple Sclerosis

  • instability problem

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Somogy Megyei Kaposi Mór Oktató Kórház Kaposvár Somogy Hungary 7400

Sponsors and Collaborators

  • Somogy Megyei Kaposi Mór Teaching Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Tollár József, Dr. József Tollár, Head of Neurorehabilitation ,7400 Kaposvár, Tallián Gy. u 20-32, Somogy Megyei Kaposi Mór Teaching Hospital
ClinicalTrials.gov Identifier:
NCT04550650
Other Study ID Numbers:
  • IKEB2020/08
First Posted:
Sep 16, 2020
Last Update Posted:
Apr 5, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tollár József, Dr. József Tollár, Head of Neurorehabilitation ,7400 Kaposvár, Tallián Gy. u 20-32, Somogy Megyei Kaposi Mór Teaching Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022