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

Primary Purpose

Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Primary Progressive

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Training groupe
PNF
Spinning grp
Balance
Sponsored by
Somogy Megyei Kaposi Mór Teaching Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring multiple sclerosis, posture, neurorehabilitation, balance

Eligibility Criteria

35 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Multiple Sclerosis
  • instability problem

Exclusion Criteria:

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

Sites / Locations

  • Somogy Megyei Kaposi Mór Oktató Kórház

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Controll

Training grp

PNF

Spinning group

Balance

Arm Description

No intervention

Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training

2 years long, You have only treated patients with the PNF technique.

Patients developed endurance for 2 years. They worked using a spinning bike.

Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance

Outcomes

Primary Outcome Measures

Postural instability
Body sway (mm) (Posturography test)
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)
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 )
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)
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)
MSIS-29
Multiple Sclerosis Questionnaire

Secondary Outcome Measures

Full Information

First Posted
September 10, 2020
Last Updated
March 24, 2022
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04550650
Brief Title
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Official Title
Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2018 (Actual)
Primary Completion Date
April 6, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Primary Progressive
Keywords
multiple sclerosis, posture, neurorehabilitation, balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Controll
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Training grp
Arm Type
Experimental
Arm Description
Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
Arm Title
PNF
Arm Type
Experimental
Arm Description
2 years long, You have only treated patients with the PNF technique.
Arm Title
Spinning group
Arm Type
Experimental
Arm Description
Patients developed endurance for 2 years. They worked using a spinning bike.
Arm Title
Balance
Arm Type
Experimental
Arm Description
Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance
Intervention Type
Other
Intervention Name(s)
Training groupe
Intervention Description
Using virtual training
Intervention Type
Other
Intervention Name(s)
PNF
Intervention Description
PNF technique was used
Intervention Type
Other
Intervention Name(s)
Spinning grp
Intervention Description
They only worked with spinning bikes.
Intervention Type
Other
Intervention Name(s)
Balance
Intervention Description
Balance development was done
Primary Outcome Measure Information:
Title
Postural instability
Description
Body sway (mm) (Posturography test)
Time Frame
2 years
Title
EQ-5D quality of life
Description
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)
Time Frame
2 years
Title
balance test
Description
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 )
Time Frame
2 years
Title
mobility test
Description
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)
Time Frame
2 years
Title
depression scale
Description
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)
Time Frame
2 years
Title
MSIS-29
Description
Multiple Sclerosis Questionnaire
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Multiple Sclerosis instability problem Exclusion Criteria: • Severe heart problems, severe demeanor, alcoholism, drug problems
Facility Information:
Facility Name
Somogy Megyei Kaposi Mór Oktató Kórház
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/?term=MS+rehabilitation
Description
Related Info

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

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