NEUROlogic rehabilitation with GAIT training using body weight support
NEUROGAIT Study – the effect of body weight supported treadmill training combined with neurologic music therapy on gait parameters and locomotor symmetry in neurological patients: a prospective randomized controlled trial
What it found
No result yet.
What it measured
Main measures
1. Change in spatiotemporal gait parameters (step length, gait speed, gait cycle) measured using the Biodex Gait Trainer 3 from baseline (T0) to post-intervention (T1) 2. Change in gait symmetry, assessed by stance time and step length (right vs. left limb) and coefficient of variation within the gait cycle, measured with the Biodex Gait Trainer 3 from T0 to T1 3. Comparison of locomotor outcomes
MRI lesionsWalking and mobility
Other measures (1)
The following functional independence and mobility secondary outcomes will be assessed from T0 to T1 (and T2, optional) using: 1. Barthel Index 2. Timed Up and Go (TUG) 3. 10-Meter Walk Test (10MWT) 4. Rivermead Motor Assessment – Gross Function 5. Patient Locomotion Ability Form (classification of mobility with/without aids) 6. Modified Ashworth Scale (muscle tone) 7. Medical Research Council (MR
MRI lesionsWalking and mobilityPhysical functionSpasticityQuality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 80
Show the full criteria
Inclusion criteria
Inclusion: 1. Age: 18–80 years 2. Sex/Gender: Women and men; no sex-based recruitment preferences 3. Neurological diagnosis (e.g., ischemic or hemorrhagic stroke, spinal cord injury, multiple sclerosis) 4. Time since neurological event: ≥3 weeks; up to several years (stable subacute or chronic phase) 5. Mobility status: Able to ambulate with an orthopedic aid and/or therapist assistance 6. Medical fitness: Clinical status permitting participation in gait training (as assessed by the attending physician and physiotherapist) 7. Cognitive capacity: Sufficient to understand instructions and provide written informed consent Exclusion: 1. Unstable cardiac or pulmonary disease 2. Severe cognitive impairment (MMSE < 24 or AMTS < 9) 3. Severe lower limb spasticity (Modified Ashworth Scale > 3) 4. History of orthopedic surgery, preventing gait training 5. Hypersensitivity or significant discomfort related to sounds or music6
Exclusion criteria
Not separately supplied in the registry.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Background and study aims Many people who have had a stroke, spinal cord injury, or multiple sclerosis have difficulties with walking. Rehabilitation usually includes physiotherapy exercises to improve strength, balance, and movement. This study aims to find out if using a treadmill with body weight support, together with rhythmic music therapy (neurologic music therapy), can help patients improve their walking ability more than standard rehabilitation alone. Who can participate? Patients aged 18 to 80 years will be invited to take part while staying in a neurological rehabilitation ward. What does the study involve? Every patient will receive standard physiotherapy. In addition, one group will also train on a treadmill (BIODEX Gait Trainer 3) with partial body weight support and music therapy. The other group will continue with standard therapy only, without treadmill training or music. The training will last for 4 weeks, with 3–5 sessions each week, each lasting around 20–30 minutes. The study will measure walking ability before therapy (T0), after 4 weeks of therapy (T1), and again after 4 weeks of follow-up (T2, optional). Assessments will include step length, walking speed, gait cycle, gait symmetry, independence in daily activities, use of walking aids, and quality of life questionnaires. What are the possible benefits and risks of participating? By comparing the results, it is hoped to confirm whether adding treadmill training with music therapy is more effective in improving gait, mobility, and quality of life in people with neurological conditions. The risks of participating in this study are minimal. Some patients may feel temporary fatigue, muscle soreness, or balance difficulties during treadmill training. There is also a small risk of falls, but all sessions will be supervised by trained physiotherapists and conducted with safety harnesses and body weight support. Music therapy does not involve medical risk, though some participants may find rhythmic stimulation uncomfortable. Participation is voluntary, and patients may withdraw at any time without affecting their medical care. Where is the study run from? Wroclaw Medical University, Poland When is the study starting and how long is it expected to run for? May 2025 to June 2027 Who is funding the study? Wroclaw Medical University, Poland Who is the main contact? Dr Wojciech T Laber, Wroclaw Medical University, wojciech.t.laber@umw.edu.pl.
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History
Started
Jul 2025
Finished
Jun 2027