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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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MS (Multiple Sclerosis)

Intervention / Treatment
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* Other: Deep sensory assisted rehabilitation
* Other: classical rehabilitation


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: classic rehabilitation group vs.deep sensory assisted rehabilitation group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Classical physical therapy and rehabilitation program<br>Classical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes. | Other: classical rehabilitation<br>* 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)<br>|
| Experimental: Deep sensory asisted therapy and rehabilitation program<br>Deep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes. | Other: Deep sensory assisted rehabilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multipl sclerosis quality of life-54(MSQOL-54) | : 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. | 1st day: when rehabilitation applications started | 
| Multipl sclerosis quality of life-54(MSQOL-54) | : 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. | after 7 weeks: when rehabilitation applications ended | 
| MiniBest test | minimum and maximum score: 0-28: high score indicates good functional balance | 1st day: when rehabilitation applications started | 
| MiniBest test | minimum and maximum score: 0-28: high score indicates good functional balance | after 7 weeks: when rehabilitation applications ended | 
| 10 meter walking time | The patient's walking time of the determined 10-meter distance is measured. | 1st day: when rehabilitation applications started | 
| 10 meter walking time | The patient's walking time of the determined 10-meter distance is measured. | after 7 weeks: when rehabilitation applications ended | 
| Nottingham Extended Activities of Daily Living Scale | minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living. | 1st day: when rehabilitation applications started | 
| Nottingham Extended Activities of Daily Living Scale | minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living. | after 7 weeks: when rehabilitation applications ended | 
| Functional Ambulation Classification | minimum and maximum score :0-5: high score indicates that walking can be done independently. | 1st day: when rehabilitation applications started | 
| Functional Ambulation Classification | minimum and maximum score :0-5: high score indicates that walking can be done independently. | after 7 weeks: when rehabilitation applications ended | 
| Fatigue Severity Score | A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue | 1st day: when rehabilitation applications started | 
| Fatigue Severity Score | A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue | after 7 weeks: when rehabilitation applications ended | 
| DN4(Douleur Neuropathique 4 Questions) | Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain. | 1st day: when rehabilitation applications started | 
| DN4(Douleur Neuropathique 4 Questions) | Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain. | after 7 weeks: when rehabilitation applications ended | 
| MSWS-12( MS walking scale-12) | minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability. | 1st day: when rehabilitation applications started | 
| MSWS-12( MS walking scale-12) | minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability. | after 7 weeks: when rehabilitation applications ended | 
| FES-1: (Falls Efficay Scale-1) | minimum and maximum score: 16-64: higher score indicates increased anxiety about falling | 1st day: when rehabilitation applications started | 
| FES-1: (Falls Efficay Scale-1) | minimum and maximum score: 16-64: higher score indicates increased anxiety about falling | after 7 weeks: when rehabilitation applications ended | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep sensory assisted rehabilitation, MS gait and balance, deep sensory walkway