Clinical trial NCT05991297: Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis
Official title: Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: MS (Multiple Sclerosis)
Keywords: deep sensory assisted rehabilitation
MS gait and balance
deep sensory walkway
Lead sponsor: Romatem Bursa Hospital
Sponsor class: OTHER
Collaborators: name: Bursa Sevket Yilmaz Training and Research Hospital
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: classic rehabilitation group vs.deep sensory assisted rehabilitation group
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Multipl sclerosis quality of life-54(MSQOL-54)
timeFrame: 1st day: when rehabilitation applications started
measure: Multipl sclerosis quality of life-54(MSQOL-54)
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: MiniBest test
timeFrame: 1st day: when rehabilitation applications started
measure: MiniBest test
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: 10 meter walking time
timeFrame: 1st day: when rehabilitation applications started
measure: 10 meter walking time
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: Nottingham Extended Activities of Daily Living Scale
timeFrame: 1st day: when rehabilitation applications started
measure: Nottingham Extended Activities of Daily Living Scale
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: Functional Ambulation Classification
timeFrame: 1st day: when rehabilitation applications started
measure: Functional Ambulation Classification
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: Fatigue Severity Score
timeFrame: 1st day: when rehabilitation applications started
measure: Fatigue Severity Score
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: DN4(Douleur Neuropathique 4 Questions)
timeFrame: 1st day: when rehabilitation applications started
measure: DN4(Douleur Neuropathique 4 Questions)
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: MSWS-12( MS walking scale-12)
timeFrame: 1st day: when rehabilitation applications started
measure: MSWS-12( MS walking scale-12)
timeFrame: after 7 weeks: when rehabilitation applications ended
measure: FES-1: (Falls Efficay Scale-1)
timeFrame: 1st day: when rehabilitation applications started
measure: FES-1: (Falls Efficay Scale-1)
timeFrame: after 7 weeks: when rehabilitation applications ended
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
state: Yildirim
city: Bursa
country: Turkey
facility: Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital
Study officials:
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: NERMİN ÇALIŞIR
role: STUDY_CHAIR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: NURTEN KÜÇÜKÇAKIR
role: STUDY_DIRECTOR
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: MERAL SEFEROĞLU
role: STUDY_DIRECTOR
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: ALİ ÖZHAN SIVACI
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: CELAL BATUHAN GÜNEYSU
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: İSMAİL HACIOĞLU
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: YUSUF ZİYA ŞAHİN
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: MUHAMMED SOC HASANOĞLU
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: MAHMUT CAN ERDOĞAN
role: PRINCIPAL_INVESTIGATOR
affiliation: ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
name: SİNAN ATİLLA
role: PRINCIPAL_INVESTIGATOR
References: