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

NCT ID: NCT05991297

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2024-06-01

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.

Conditions

MS (Multiple Sclerosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Classical physical therapy and rehabilitation program

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

Group Type: ACTIVE_COMPARATOR

classical rehabilitation

Intervention Type: 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)

Deep sensory asisted therapy and rehabilitation program

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

Group Type: EXPERIMENTAL

Deep sensory assisted rehabilitation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Sevket Yilmaz Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

Nermin Çalışır

OTHER

Sponsor Role: lead

Responsible Party

Nermin Çalışır

Principal İnvestigator,Head of Neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

NERMİN ÇALIŞIR

Role: STUDY_CHAIR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

NURTEN KÜÇÜKÇAKIR

Role: STUDY_DIRECTOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

MERAL SEFEROĞLU

Role: STUDY_DIRECTOR

Bursa Yuksek Ihtisas Training and Research Hospital

ALİ ÖZHAN SIVACI

Role: PRINCIPAL_INVESTIGATOR

Bursa Yuksek Ihtisas Training and Research Hospital

CELAL BATUHAN GÜNEYSU

Role: PRINCIPAL_INVESTIGATOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

İSMAİL HACIOĞLU

Role: PRINCIPAL_INVESTIGATOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

YUSUF ZİYA ŞAHİN

Role: PRINCIPAL_INVESTIGATOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

MUHAMMED SOC HASANOĞLU

Role: PRINCIPAL_INVESTIGATOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

MAHMUT CAN ERDOĞAN

Role: PRINCIPAL_INVESTIGATOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

SİNAN ATİLLA

Role: PRINCIPAL_INVESTIGATOR

ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

Locations

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yildirim, Turkey (Türkiye)

Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ROMATEM-NERMİN ÇALIŞIR 2023

Identifier Type: -

Identifier Source: org_study_id