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

Sponsor

Nermin Çalışır (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05991297

Collaborator

Bursa Sevket Yilmaz Training and Research Hospital (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
MS (Multiple Sclerosis)	Other: Deep sensory assisted rehabilitation Other: classical rehabilitation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

classic rehabilitation group vs.deep sensory assisted rehabilitation groupclassic rehabilitation group vs.deep sensory assisted rehabilitation group

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Classical physical therapy and rehabilitation program

Classical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes.

Other: classical rehabilitation

Experimental: Deep sensory asisted therapy and rehabilitation program

Deep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes.

Other: Deep sensory assisted rehabilitation

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital	Bursa	Yildirim	Turkey
2	Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital	Bursa		Turkey	16030

Sponsors and Collaborators

Nermin Çalışır
Bursa Sevket Yilmaz Training and Research Hospital

Investigators

Study Chair: NERMİN ÇALIŞIR, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Study Director: NURTEN KÜÇÜKÇAKIR, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Study Director: MERAL SEFEROĞLU, UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
Principal Investigator: ALİ ÖZHAN SIVACI, UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
Principal Investigator: CELAL BATUHAN GÜNEYSU, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Principal Investigator: İSMAİL HACIOĞLU, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Principal Investigator: YUSUF ZİYA ŞAHİN, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Principal Investigator: MUHAMMED SOC HASANOĞLU, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Principal Investigator: MAHMUT CAN ERDOĞAN, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Principal Investigator: SİNAN ATİLLA, ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL