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.

Study Overview

• Status: Completed
• Conditions: MS (Multiple Sclerosis)
• Intervention / Treatment: Other: classical rehabilitation; Other: Deep sensory assisted rehabilitation

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Bursa, Turkey (Türkiye), 16030
    • ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
  • Yildirim
    • Bursa, Yildirim, Turkey (Türkiye)
      • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nermin Çalışır
• Collaborators: 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; 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; Study Director: MERAL SEFEROĞLU, Bursa Yuksek Ihtisas Training and Research Hospital; Principal Investigator: ALİ ÖZHAN SIVACI, Bursa Yuksek Ihtisas Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): June 1, 2024

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 10, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: deep sensory assisted rehabilitation; MS gait and balance; deep sensory walkway
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: ROMATEM-NERMİN ÇALIŞIR 2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No