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

NCT03424538 — Not applicable, Completed, 2 participants, Somogy Megyei Kaposi Mór Teaching Hospital

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

Registry	NCT03424538
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	2 (Actual)
Sponsor	Somogy Megyei Kaposi Mór Teaching Hospital (Other); collaborators: University Medical Center Groningen
Conditions	Multiple Sclerosis, Chronic Progressive, Multiple Sclerosis, Primary Progressive
Interventions	Neurorehabilitation, Physiotherapy (Other)
Dates	start 2018-02-05, primary completion 2018-04-16, completion 2018-06-10, first posted 2018-02-07, last updated 2020-04-28
Locations	1 site in Hungary

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
MSt	Experimental	Other: Neurorehabilitation	The MSt group that received 5 weeks of intensive therapy.
MSc	No intervention		The MS controll group that did not receive treatment.
MStp	Experimental	Other: Physiotherapy	The MStp Group performs a traditional physiotherapy for 5 weeks.

Neurorehabilitation (Other): 5-week-long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
Physiotherapy (Other): 5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 35 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* Multiple Sclerosis
* instability problem

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Somogy Megyei Kaposi Mór Teaching Hospital	Kaposvár, Somogy County	Hungary

+Investigators

József Tollár, MSC, Principal investigator, Somogy Megyei Kaposi Mór Teaching Hospital

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