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

Multiple Sclerosis, Primary Progressive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550650
• Other study ID #: IKEB2020/08
• Status: Completed
• Phase: N/A
• Start date: April 6, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: March 2022
• Source: Somogy Megyei Kaposi Mór Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 1, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Multiple Sclerosis

• instability problem

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Multiple Sclerosis, Primary Progressive
• Sclerosis

Intervention

Other:
• Training groupe
Using virtual training
• PNF
PNF technique was used
• Spinning grp
They only worked with spinning bikes.
• Balance
Balance development was done

Locations

Country	Name	City	State
Hungary	Somogy Megyei Kaposi Mór Oktató Kórház	Kaposvár	Somogy

Sponsors (1)

Lead Sponsor	Collaborator
Somogy Megyei Kaposi Mór Teaching Hospital

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural instability	Body sway (mm) (Posturography test)	2 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	MSIS-29	Multiple Sclerosis Questionnaire	2 years

External Links

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