The Effect of Neurorehabilitation Therapy on Postural Control, Mobility and Quality of Life in Multiple Sclerosis Patients

Sponsor

Somogy Megyei Kaposi Mór Teaching Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03424538

Collaborator

University Medical Center Groningen (Other)

Enrollment

Location

Arms

4.1

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Primary Progressive	Other: Neurorehabilitation Other: Physiotherapy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

The Effect of Variable Intensity Work on Postural Instability, Motion Performance and Quality of Life in Multiple Sclerosis Patients

Actual Study Start Date :

Feb 5, 2018

Actual Primary Completion Date :

Apr 16, 2018

Actual Study Completion Date :

Jun 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MSt The MSt group that received 5 weeks of intensive therapy.	Other: Neurorehabilitation 5-week-long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
No Intervention: MSc The MS controll group that did not receive treatment.
Experimental: MStp The MStp Group performs a traditional physiotherapy for 5 weeks.	Other: Physiotherapy 5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening

Arm

Intervention/Treatment

Experimental: MSt

The MSt group that received 5 weeks of intensive therapy.

Other: Neurorehabilitation

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

No Intervention: MSc

The MS controll group that did not receive treatment.

Experimental: MStp

The MStp Group performs a traditional physiotherapy for 5 weeks.

Other: Physiotherapy

5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening

Outcome Measures

Primary Outcome Measures

Postural instability [5 weeks]
Body sway (mm) (Posturography test)
quality of life [5 weeks]
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 [5 weeks]
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 [5 weeks]
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 [5 weeks]
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)

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 Teaching Hospital	Kaposvár	Somogy	Hungary	7400

Sponsors and Collaborators

Somogy Megyei Kaposi Mór Teaching Hospital
University Medical Center Groningen

Investigators

Principal Investigator: József Tollár, MSC, Somogy Megyei Kaposi Mór Teaching Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

description related info

Publications

None provided.

Responsible Party:

Tollár József, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital

ClinicalTrials.gov Identifier:

NCT03424538

Other Study ID Numbers:

IKEB008/2017

First Posted:

Feb 7, 2018

Last Update Posted:

Apr 28, 2020

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Tollár József, Principal Investigator, Somogy Megyei Kaposi Mór Teaching Hospital

Additional relevant MeSH terms:

Multiple Sclerosis

Multiple Sclerosis, Chronic Progressive

Sclerosis

Study Results

No Results Posted as of Apr 28, 2020