The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients
Primary Purpose
Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Primary Progressive
Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Neurorehabilitation
Physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis, Chronic Progressive focused on measuring multiple sclerosis, posture, neurorehabilitation, balance
Eligibility Criteria
Inclusion Criteria:
- Multiple Sclerosis
- instability problem
Exclusion Criteria:
- Severe heart problems, severe demeanor, alcoholism, drug problems
Sites / Locations
- Somogy Megyei Kaposi Mór Teaching Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
Experimental
Arm Label
MSt
MSc
MStp
Arm Description
The MSt group that received 5 weeks of intensive therapy.
The MS controll group that did not receive treatment.
The MStp Group performs a traditional physiotherapy for 5 weeks.
Outcomes
Primary Outcome Measures
Postural instability
Body sway (mm) (Posturography test)
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT03424538
First Posted
January 18, 2018
Last Updated
April 26, 2020
Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT03424538
Brief Title
The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients
Official Title
The Effect of Variable Intensity Work on Postural Instability, Motion Performance and Quality of Life in Multiple Sclerosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
April 16, 2018 (Actual)
Study Completion Date
June 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Somogy Megyei Kaposi Mór Teaching Hospital
Collaborators
University Medical Center Groningen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Abstract Introduction: Postural control disorders are the most common motor disorder associated with multiple sclerosis.
Objective: The aim of this study is to demonstrate the potential for improvement of postural control, motion performance and quality of life in patients with multiple sclerosis who are performing a special neurorevolutionary balancing program.
Intervention: The treated group (n = 15) performed five times a week for the treatment we defined. (60 minutes per day). The experimental group performed movements using the Xbox 360 and Kinect consoles. The study team participated in 25 sessions, five times a week. The duration of treatment was 5 weeks.The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. Sensory Organisation Test / Body Sway at the end of the baseline and treatment protocol is used to evaluate each patient. The quality of life mapping was measured by subjective tests (EQ-5D-5L, ADL). To assess the depressive state, a Beck depression questionnaire was used. Balance and motion performance were used by the Berg Balance Test and 6Minutes Walk Test. The results were compared with the control group results (n = 14) and showed improvement in overall balance and motion performance.
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
Model Description
The single-arm, 5-week intervention is monitor every day on the effect of postural control on walking performance, balance and quality of life. The intervention team (n = 15) takes 25 training sessions for 5 weeks. Every move takes 60 minutes to continuously increase the load intensity of the X-box program. Before each intervention started, the patients perform a 10 minute warm-up and the drainage exercises are 15 minutes stretching exercises. The MStp group (n=14) participated in a 5-week physiotherapy course. The general treatment consisted of strengthening, stretching and walking correction. During the 5-week period, 25 patients attended training. One treatment takes 60 minutes. The control group (n = 14) did not receive physiotherapeutic treatment outside the medication.
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MSt
Arm Type
Experimental
Arm Description
The MSt group that received 5 weeks of intensive therapy.
Arm Title
MSc
Arm Type
No Intervention
Arm Description
The MS controll group that did not receive treatment.
Arm Title
MStp
Arm Type
Experimental
Arm Description
The MStp Group performs a traditional physiotherapy for 5 weeks.
Intervention Type
Other
Intervention Name(s)
Neurorehabilitation
Intervention Description
5-week-long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening
Primary Outcome Measure Information:
Title
Postural instability
Description
Body sway (mm) (Posturography test)
Time Frame
5 weeks
Title
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
5 weeks
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
5 weeks
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
5 weeks
Secondary Outcome Measure Information:
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
5 weeks
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
József Tollár, MSC
Organizational Affiliation
Somogy Megyei Kaposi Mór Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Somogy Megyei Kaposi Mór Teaching Hospital
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=multiple+sclerosis+rehabilitation+wii
Description
description related info
Learn more about this trial
The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients
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