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Completed

NCT Number: NCT05991297

Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis

The effect of physical therapy and rehabilitation on improving the gait and balance disorders of patients has been proven. FTR applications in MS patients have become routine in developed countries. However, due to the high patient density in our country, FTR cannot be performed at the rate we want due to different reasons such as the inability to separate areas special for MS patients, the lack of special FTR applications for MS patients, and the inability to perform regular FTR follow-ups. Even if FTR is recommended and performed, our patients think that FTR is not very effective due to the above reasons and they do not continue.

A team of neurology, physical therapy specialists, and physiotherapists was formed, in-service training was completed and a special rehabilitation program for MS patients was created. First of all, we will apply routine classical FTR to our patients. Sensory and deep sensory disorders, which are more common and severe, especially in the lower extremities, also negatively affect gait and balance.

A rehabilitation program was created by adding exercises to improve sensation and deep sense, along with muscle strengthening. The results of the 1st and 21st sessions of the patients in the two groups who underwent classical rehabilitation and deep sensory-assisted rehabilitation will be compared. It was planned to evaluate the gait and balance parameters of the patients as numerical data with clinical scales and the C mill device we used in walking and balance exercises.

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Key information

Conditions

MS (Multiple Sclerosis) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital, Bursa, Yildirim, Turkey (Türkiye)

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About this study

Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped); increase in exercise capacity, duration, distance; An increase in the number of steps per minute and step length is expected.

It was thought that both classical rehabilitation and deep sensory-assisted rehabilitation would improve gait and balance parameters.

There has been previous research showing the effects of FTR. What we will do in addition and new with this research;

  • The effects of classical rehabilitation and deep sensory-assisted rehabilitation will be compared
  • A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.
  • the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.
  • Most of the previous studies have shown the effect of FTR using clinical scales. In developed countries, gait analysis was performed. In our research, we aimed to measure gait and balance parameters in C-mill walking and balance exercise devices, together with clinical scales, as numerical data and graphics. The patient's standing and walking on the treadmill, stride length, stride symmetry, walking speed, distance, duration, cadence, and percentage deviation from targets during tandem and slalom walking parameters will be recorded as objective numerical data and graphics. These measurements will be recorded in the 1st session and the 21st session.

Changes in patients will be seen with clinical scales and visual evaluations. However, in order to make the evaluation more objective for both the patient and the practitioner, these measurements made with the C mill will also be made.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with multiple sclerosis
  • 20-60 years old
  • EDSS between 3.0-5.5 Those with EDSS 0-2.5 and spinal and/or cerebellar involvement
  • Had the last MS attack at least 3 months ago

Exclusion criteria

  • schizoaffective disorder
  • lower extremity amputation
  • shortness on one side creating asymmetry in the lower extremities
  • diabetes mellitus
  • cognitive impairment (at a level that may interfere with communication)

Treatment and study plan

Deep sensory assisted rehabilitation

Other

A new PTR plan called "deep sensory assisted rehabilitation" was created: it was aimed to develop a sensory and deep sense in the adult age group by making use of sensory integration exercises, which are mostly applied in the childhood age group. Whether these exercises are effective on walking and balance will be evaluated. Patients will be dressed in a vest with an equally distributed weight of 4-6 kg according to their weight, and exercises will be done while walking and standing.

  • the so-called "deep sensory pathway"; The patients will be given standing and walking exercises on sand and stone floors, soft floors made of sponge, hard plastic floors with different sizes of grooves and shapes, and hot-cold floors formed by placing hot packs and cold packs.

classical rehabilitation

Other

Muscle strengthening in all four extremities; strengthening of trunk and abdominal muscles; providing and maintaining joint range of motion; independent and safe standing, turning, and stepping; able to walk alone on flat ground and on different surfaces (such as sloping-handicapped-soil-stone-sand-grass-rough-stepped)

Primary outcomes

  1. Multipl sclerosis quality of life-54(MSQOL-54)

    Time frame: 1st day: when rehabilitation applications started

    : It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively.

  2. Multipl sclerosis quality of life-54(MSQOL-54)

    Time frame: after 7 weeks: when rehabilitation applications ended

    : It is calculated with the combined summary scores of physical and mental health. As the total score increases, the quality of life is evaluated positively. The scale has not minimum and maximum value. The change between the participant's prior and values was evaluated.

  3. MiniBest test

    Time frame: 1st day: when rehabilitation applications started

    minimum and maximum score: 0-28: high score indicates good functional balance

  4. MiniBest test

    Time frame: after 7 weeks: when rehabilitation applications ended

    minimum and maximum score: 0-28: high score indicates good functional balance

  5. 10 meter walking time

    Time frame: 1st day: when rehabilitation applications started

    The patient's walking time of the determined 10-meter distance is measured.

  6. 10 meter walking time

    Time frame: after 7 weeks: when rehabilitation applications ended

    The patient's walking time of the determined 10-meter distance is measured.

  7. Nottingham Extended Activities of Daily Living Scale

    Time frame: 1st day: when rehabilitation applications started

    minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.

  8. Nottingham Extended Activities of Daily Living Scale

    Time frame: after 7 weeks: when rehabilitation applications ended

    minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.

  9. Functional Ambulation Classification

    Time frame: 1st day: when rehabilitation applications started

    minimum and maximum score :0-5: high score indicates that walking can be done independently.

  10. Functional Ambulation Classification

    Time frame: after 7 weeks: when rehabilitation applications ended

    minimum and maximum score :0-5: high score indicates that walking can be done independently.

  11. Fatigue Severity Score

    Time frame: 1st day: when rehabilitation applications started

    A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue

  12. Fatigue Severity Score

    Time frame: after 7 weeks: when rehabilitation applications ended

    A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue

  13. DN4(Douleur Neuropathique 4 Questions)

    Time frame: 1st day: when rehabilitation applications started

    Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.

  14. DN4(Douleur Neuropathique 4 Questions)

    Time frame: after 7 weeks: when rehabilitation applications ended

    Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.

  15. MSWS-12( MS walking scale-12)

    Time frame: 1st day: when rehabilitation applications started

    minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.

  16. MSWS-12( MS walking scale-12)

    Time frame: after 7 weeks: when rehabilitation applications ended

    minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.

  17. FES-1: (Falls Efficay Scale-1)

    Time frame: 1st day: when rehabilitation applications started

    minimum and maximum score: 16-64: higher score indicates increased anxiety about falling

  18. FES-1: (Falls Efficay Scale-1)

    Time frame: after 7 weeks: when rehabilitation applications ended

    minimum and maximum score: 16-64: higher score indicates increased anxiety about falling

Sponsors and collaborators

Lead sponsor

Nermin Çalışır

Other

Collaborators

  • Bursa Sevket Yilmaz Training and Research Hospital

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 14, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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