Comprehensive Rehabilitation Programme in People With Multiple Sclerosis: The RECONNECT-MS Study

NCT07666958 | Not Yet Recruiting

• 2 other identifiers: CZ.02.01.01/00/24_037/0013828NG-2026-2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a comprehensive rehabilitation programme can improve physical function, reduce fatigue, and raise quality of life in adults aged 18-65 with multiple sclerosis (MS). The study will also look at whether the programme leads to changes in brain function using magnetic resonance imaging (MRI). The main questions it aims to answer are:

• Does the programme lower the overall impact of MS on daily life?
• Does the programme improve walking, balance, and hand function?
• Does the programme reduce the impact of fatigue?
• Are there changes in brain connections after the programme? Each participant serves as their own comparison. They are tested 3 times: 2 months before the programme starts (T0), right before it starts (T1), and after 2 months of intensive treatment (T2). The period between T0 and T1, when no treatment is given, shows each person's natural changes over time. Participants will:
• Attend individual physiotherapy twice a week for 2 months, then 3 follow-up sessions over the next month
• Take part in 3 group movement-awareness sessions
• Take part in 3 group psychotherapy sessions focused on stress management and relaxation
• Receive written nutritional guidance for autoimmune conditions Tests include physical assessments, questionnaires about fatigue and quality of life, tremor measurement, and brain MRI scans. The results may help improve rehabilitation care for people with MS and support their ability to stay active in everyday and working life.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Rehabilitation; Physiotherapy; Psychotherapy; Neuroplasticity; Functional Magnetic Resonance Imaging; Quality of Life; Fatigue; Self-Controlled Design; Comprehensive Care; Motor Programme Activating Therapy; Physical Therapy Modalities; Neurological Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in MS-specific health impact (Multiple Sclerosis Impact Scale, MSIS-29 total score)

  The MSIS-29 is a 29-item patient-reported outcome assessing the physical (20 items) and psychological (9 items) impact of multiple sclerosis on daily life over the past 2 weeks. Each item is rated on a 5-point scale; the total score is transformed to a 0-100 metric (higher scores indicate greater impact of MS). MSIS-29 was selected as the primary outcome because it captures the comprehensive impact of MS on the participant's life and is the most representative measure of the study's primary aim. Also assessed at T0 (2 months before T1) to characterise within-subject stability during the no-intervention control period. Sample size (n=45) was not determined on MSIS-29, but conservatively on MFIS, the only pilot-study outcome non-significant at n=20 (MCID 4, SD 8.6, α=0.05, 1-β=0.8); MSIS-29 was significant in the pilot at n=20.

  Change from baseline (T1, immediately before intervention start) to T2 (2-month intensive intervention phase)

Secondary Outcomes (14)

• Change in dynamic balance and stepping (Four Square Step Test, FSST)

  Change from baseline (T1) to T2 (2 months of intensive intervention)

• Change in walking endurance (Two-Minute Walk Test, 2MWT)

  Change from baseline (T1) to T2 (2 months of intensive intervention)

• Change in upper limb fine motor function (Nine Hole Peg Test, NHPT)

  Change from baseline (T1) to T2 (2 months of intensive intervention)

• Change in upper limb tremor dominant frequency (inertial sensors)

  Change from baseline (T1) to T2 (2 months of intensive intervention)

• Change in upper limb tremor spectral power (inertial sensors)

  Change from baseline (T1) to T2 (2 months of intensive intervention)

Other Outcomes (2)

• Change in functioning, disability, and health profile (ICF Brief Core Set for Multiple Sclerosis)

  Baseline (T0, 2 months before intervention start) and post-intensive phase (T2, 2 months of intensive intervention) - spanning 4 months total

• Participant-reported satisfaction and acceptability of the programme

  End of 3-month programme

Study Arms (1)

Comprehensive Rehabilitation Programme

EXPERIMENTAL

Participants receive a 3-month multidisciplinary rehabilitation programme combining individual physiotherapy (twice weekly for 2 months, followed by 3 maintenance sessions over the 3rd month), 3 group movement-awareness sessions (Feldenkrais ATM), 3 group psychotherapy sessions, and written nutritional recommendations.

Behavioral: Individual Physiotherapy; Behavioral: Group Movement Awareness; Behavioral: Group Psychotherapy; Other: Nutritional Recommendations

Interventions

Individual Physiotherapy BEHAVIORAL

Facilitation-based individual physiotherapy (Motor Programme Activating Therapy, Dynamic Neuromuscular Stabilisation, soft-tissue and mobilisation techniques). 50 minute sessions, twice weekly for 8 weeks, then 3 maintenance sessions at progressively extended intervals during weeks 9-12. Delivered by two alternating physiotherapists.

Comprehensive Rehabilitation Programme

Group Movement Awareness BEHAVIORAL

Three small-group sessions (6-8 participants) of Feldenkrais Awareness Through Movement (ATM).

Comprehensive Rehabilitation Programme

Group Psychotherapy BEHAVIORAL

Three 60-minute small-group sessions focused on stress management, emotion regulation, relaxation techniques, and psychoeducation.

Comprehensive Rehabilitation Programme

Nutritional Recommendations OTHER

Written / online evidence-based nutritional recommendations for autoimmune disease.

Comprehensive Rehabilitation Programme

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unambiguous clinical diagnosis of multiple sclerosis (any subtype, including relapsing-remitting, secondary progressive, and primary progressive)
• Age 18-65 years
• Predominantly motor disability with Expanded Disability Status Scale (EDSS) 2-6
• No relapse within the past month
• Able to attend outpatient physiotherapy regularly and motivated to participate in the programme
• Able and willing to complete 3 sets of clinical examinations and 3 MRI examinations

You may not qualify if:

• Conditions impairing mobility (e.g., severe injuries, orthopaedic problems, other neurological conditions)
• Acute inflammatory conditions or infections at the time of programme initiation that could affect the results or safety of the participant
• Change or planned change of treatment (including disease-modifying therapy or corticosteroid therapy) within the past month or during the programme
• Contraindications to MRI examination (e.g., first-trimester pregnancy, presence of a pacemaker, defibrillator, older metallic joint replacements, or other metallic implants)
• Long-term planned absence during the programme (e.g., holiday, surgical procedure)

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• Institute for Clinical and Experimental Medicine: collaborator
• Faculty Hospital Kralovske Vinohrady: collaborator
• Czech Ministry of Education: collaborator

Study Sites (1)

University Hospital Kralovske Vinohrady, Department od Rehabilitation Medicine

Prague, Czech Republic, 10034, Czechia

Location

Related Publications (4)

• Rasova K, Prochazkova M, Tintera J, Ibrahim I, Zimova D, Stetkarova I. Motor programme activating therapy influences adaptive brain functions in multiple sclerosis: clinical and MRI study. Int J Rehabil Res. 2015 Mar;38(1):49-54. doi: 10.1097/MRR.0000000000000090.

  PMID: 25325167 BACKGROUND

• Miznerova B, Reissigova J, Vasa L, Frank J, Hudec M, Rodina L, Herynkova A, Havlik J, Tintera J, Rydlo J, Ibrahim I, O'Leary VB, Cerna M, Jurickova I, Pokorna M, Philipp T, Hlinovska J, Stetkarova I, Rasova K. Virtual reality-based neuroproprioceptive physiotherapy in multiple sclerosis: a protocol for a double-arm randomised assessor-blinded controlled trial on upper extremity function, postural function and quality of life, with molecular and functional MRI assessment. BMJ Open. 2025 Jan 9;15(1):e088046. doi: 10.1136/bmjopen-2024-088046.

  PMID: 39788766 BACKGROUND

• Prochazkova M, Tintera J, Spanhelova S, Prokopiusova T, Rydlo J, Pavlikova M, Prochazka A, Rasova K. Brain activity changes following neuroproprioceptive "facilitation, inhibition" physiotherapy in multiple sclerosis: a parallel group randomized comparison of two approaches. Eur J Phys Rehabil Med. 2021 Jun;57(3):356-365. doi: 10.23736/S1973-9087.20.06336-4. Epub 2020 Sep 16.

  PMID: 32935954 BACKGROUND

• Hruskova N, Berchova Bimova K, Davies Smith A, Skodova T, Bicikova M, Kolatorova L, Stetkarova I, Brozek L, Javurkova A, Angelova G, Rasova K. People with newly diagnosed multiple sclerosis benefit from a complex preventative intervention-a single group prospective study with follow up. Front Neurol. 2024 Apr 10;15:1373401. doi: 10.3389/fneur.2024.1373401. eCollection 2024.

  PMID: 38660088 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kamila Rasova, prof. Ph.D.

  Faculty Hospital Kralovske Vinohrady and Charles University in Prague, Czech Republic

  STUDY DIRECTOR

• Marie Prochazkova, Ph.D.

  Faculty hospital Kralovske Vinohrady, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Prochazkova, Ph.D.

CONTACT

+420737449662; prochazkova777@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.

Model Details: Single-arm interventional study with a self-controlled (within-subject) design. Each participant serves as their own control. Outcomes are assessed at three time points: 2 months before the intervention starts (T0, control measurement), immediately before the intervention starts (T1, baseline), and after the 2-month intensive phase of the intervention (T2). The T0-T1 interval (no intervention) provides a within-subject control period that allows the change attributable to the intervention (T1→T2) to be compared against spontaneous within-subject variability (T0→T1).

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

CZ (1)