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

NCT03424538 | Completed DMC

• 1 other identifier: IKEB008/2017
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive

Keywords

multiple sclerosis; posture; neurorehabilitation; balance

Outcome Measures

Primary Outcomes (4)

• Postural instability

  Body sway (mm) (Posturography test)

  5 weeks

• 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)

  5 weeks

• 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 )

  5 weeks

• 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)

  5 weeks

Secondary Outcomes (1)

• depression scale

  5 weeks

Study Arms (3)

MSt

EXPERIMENTAL

The MSt group that received 5 weeks of intensive therapy.

Other: Neurorehabilitation

MSc

NO INTERVENTION

The MS controll group that did not receive treatment.

MStp

EXPERIMENTAL

The MStp Group performs a traditional physiotherapy for 5 weeks.

Other: Physiotherapy

Interventions

Neurorehabilitation OTHER

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

MSt

Physiotherapy OTHER

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

MStp

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Multiple Sclerosis
• instability problem

You may not qualify if:

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

Sponsors & Collaborators

• Somogy Megyei Kaposi Mór Teaching Hospital: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Somogy Megyei Kaposi Mór Teaching Hospital

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

• description related info

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Interventions

Neurological Rehabilitation; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• József Tollár, MSC

  Somogy Megyei Kaposi Mór Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: February 7, 2018
• Study Start: February 5, 2018
• Primary Completion: April 16, 2018
• Study Completion: June 10, 2018
• Last Updated: April 28, 2020

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)