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

Not Applicable

Completed

• Conditions: Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis, Primary Progressive
• Interventions: Other: PNF; Other: Training groupe; Other: Balance; Other: Spinning grp

• Registration Number: NCT04550650
• Lead Sponsor: Somogy Megyei Kaposi Mór Teaching Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-06
• Primary Completion: 2020-04-06
• Study Completion: 2020-09-01
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-10
• Study First Posted: 2020-09-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Multiple Sclerosis
• instability problem

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PNF	PNF	2 years long, You have only treated patients with the PNF technique.
Training grp	Training groupe	Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
Balance	Balance	Neurorehabilitation 2 years long intervention, administered daily, targeted postural instability, balance
Spinning group	Spinning grp	Patients developed endurance for 2 years. They worked using a spinning bike.

Primary Outcome Measures

Name	Time	Method
Postural instability	2 years	Body sway (mm) (Posturography test)
EQ-5D quality of life	2 years	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	2 years	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 )
depression scale	2 years	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)
mobility test	2 years	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)
MSIS-29	2 years	Multiple Sclerosis Questionnaire

Trial Locations

Locations (1)

Somogy Megyei Kaposi Mór Oktató Kórház; 🇭🇺 Kaposvár, Somogy, Hungary