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

NCT04550650 | Completed

• 1 other identifier: IKEB2020/08
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive

Keywords

multiple sclerosis; posture; neurorehabilitation; balance

Outcome Measures

Primary Outcomes (6)

• Postural instability

  Body sway (mm) (Posturography test)

  2 years

• 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)

  2 years

• 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 )

  2 years

• 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)

  2 years

• 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)

  2 years

• MSIS-29

  Multiple Sclerosis Questionnaire

  2 years

Study Arms (5)

Controll

NO INTERVENTION

No intervention

Training grp

EXPERIMENTAL

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

Other: Training groupe

PNF

EXPERIMENTAL

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

Other: PNF

Spinning group

EXPERIMENTAL

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

Other: Spinning grp

Balance

EXPERIMENTAL

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

Other: Balance

Interventions

Training groupe OTHER

Using virtual training

Training grp

PNF OTHER

PNF technique was used

PNF

Spinning grp OTHER

They only worked with spinning bikes.

Spinning group

Balance OTHER

Balance development was done

Balance

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

Study Sites (1)

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County, 7400, Hungary

Location

Related Links

• Related Info

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. József Tollár, Head of Neurorehabilitation ,7400 Kaposvár, Tallián Gy. u 20-32

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: April 6, 2018
• Primary Completion: April 6, 2020
• Study Completion: September 1, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)