Vojta therapy in multiple sclerosis rehabilitation

ISRCTN	ISRCTN12817871
DOI	https://doi.org/10.1186/ISRCTN12817871
Secondary identifying numbers	KB-807/2021

Submission date: 05/02/2022
Registration date: 16/02/2022
Last edited: 16/02/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is one of the most common causes of neurological disability that affects young adults. It is a lifelong condition that affects the brain and nerves. Gait and balance problems are one of the most common symptoms of the disease even in the early stages, affecting more than 75% of people with MS. These problems affec gait, with a great risk of falling, and also affect most daily life activities, with a great impact on quality of life.
Therefore, attention to this problem has to be taken as a priority. The aim of this study will be to compare the short- and long term effects of Vojta therapy and standard rehabilitation on gait, balance, postural control and pain.

Who can participate?
Patients aged 18 years and over with chronic low back pain

What does the study involve?
Participants will be randomly allocated to receive Vojta therapy or standard rehabilitation, 10 times in total. Gait, body balance, muscle pain and postural control will be measured before and after treatment and during follow-up visits 1 and 3 months after the end of the study.

What are the possible benefits and risks of participating?
Participants will receive a complete treatment program, which may lead to improved gait, body balance and postural control and reduced muscle pain. Risks include temporary fatigue up to 24 hours after the first exercise procedures.

Where is the study run from?
1. University of Opole (Poland)
2. Malgorzata Fuchs Fizjoterapia (Opole)

When is the study starting and how long is it expected to run for?
August 2021 to December 2023

Who is the main contact?
1. Lukasz Argier, PT, MSc
argier@o2.pl
2. Prof. Jakub Taradaj
j.taradaj@awf.katowice.pl

Contact information

Mr Lukasz Argier
Public

Nowoczesna Fizjoterapia Neurar
Zwyciestwa 2/86 Street
Opole
45-855
Poland

Phone	+48 (0)606781243
Email	argier@o2.pl

Prof Jakub Taradaj
Scientific

Academy of Physical Education
72 Mikolowska Street
Katowice
40-065
Poland

ORCID ID	0000-0002-1796-5832
Phone	+48 (0)668613945
Email	j.taradaj@awf.katowice.pl

Study information

Study design	Prospective randomized clinical study with follow-up analysis
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title	Vojta therapy improves gait and postural control in multiple sclerosis rehabilitation
Study acronym	VojtaNDT & MS
Study hypothesis	1. Vojta therapy improves gait parameters in multiple sclerosis (MS) patients compared to standard rehabilitation 2. Vojta stimulation is effective in muscle pain relief in MS 3. The Vojta approach improves body balance, stability and postural control of MS patients compared to the standard program
Ethics approval(s)	Approved 08/10/2021, Research Ethics Committee from Wroclaw Medical University (1 Pasteur Street, 50-367, Wroclaw, Poland; +48 (0)717841014; bioetyka@umed.wroc.pl), ref: KB-807/2021
Condition	Multiple sclerosis
Intervention	After baseline assessments, the participants will be randomly assigned to: 1. Vojta therapy 2. Standard rehabilitation training The individuals receiving the treatment will be blinded. A computer-generated list of random numbers will be used and concealed from the researchers enrolling and assessing the participants. The outcome assessors and data analysts will be kept blinded to the allocation The treatment protocol in the first group will include NDT Vojta exercises (once a day, three days a week) within 3 weeks. Each session will consist of a 40-min Vojta therapy protocol based on three exercises: crawling reflex and 1st phase and 2nd phase rolling reflex. The three face to face sessions will be made by the principal investigator. The participants in the second group will receive the standard rehabilitation program (50 minutes, once a day, three days a week) within 3 weeks, including balance exercises targeting core stability, exercises of coordination and proprioceptive neuromuscular facilitation (PNF) as well as individual sessions using the Bobath concept.
Intervention type	Behavioural
Primary outcome measure	Gait analysed using a medical treadmill at baseline, 4, 8 and 16 weeks
Secondary outcome measures	1. Pain assessed with the Visual Analogue Scale at baseline, 4, 8 and 16 weeks 2. Balance and postural control assessed with the Berg Balance Scale (BBS) and the Tinetti Test at baseline, 4, 8 and 16 weeks 3. Postural control measured using the Timed Walking Test and 12-item Multiple Sclerosis Walking Scale at baseline, 4, 8 and 16 weeks
Overall study start date	16/08/2021
Overall study end date	30/12/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Participant inclusion criteria	1. Final diagnosis of MS (by McDonald's criteria) 2. Relapsing-remitting stage of MS 3. Walkability with or without assistance (4.0-6 in Expanded Disability Status Scale [EDSS])
Participant exclusion criteria	1. Younger than 18 years old 2. Progressive MS 3. Phase outbreak or outbreak in the 3 months before the study 4. Medication that prevents or limits the performance of the locomotion reflex 5. Non-treated arterial hypertension 6. Cardiopulmonary incompetence 7. Pregnancy 8. Cancer 9. Active infections 10. Hepatitis B and HIV infection 11. Severe articular degeneration, including patients eligible for orthopedic surgery 12. Advanced osteoporosis 13. A history of stroke and Parkinson disease
Recruitment start date	07/03/2022
Recruitment end date	28/07/2023

Locations

Countries of recruitment

Poland

Study participating centres

University of Opole

Institute of Health Sciences
68 Katowicka Street
Opole
45-065
Poland

Małgorzata Fuchs Fizjoterapia

7 Grota Roweckiego
Opole
45-268
Poland

Sponsor information

Opole University
University/education

Institute of Health Sciences
Katowicka 68 Street
Opole
45-060
Poland

Phone	+48 (0)77 44 23 546
Email	bozena.ratajczakolszewska@uni.opole.pl
Website	https://wnoz.uni.opole.pl/
"ROR"	https://ror.org/04gbpnx96

Funders

Funder type

Hospital/treatment centre

Nowoczesna Fizjoterapia Neurar

No information available

Results and Publications

Intention to publish date	30/12/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Publications in peer-reviewed journals
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request (j.taradaj@awf.katowice.pl)

Editorial Notes

08/02/2022: Trial's existence confirmed by the Research Ethics Committee from Wroclaw Medical University.