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

NCT05991297 | Completed

• 1 other identifier: ROMATEM-NERMİN ÇALIŞIR 2023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

MS (Multiple Sclerosis)

Keywords

deep sensory assisted rehabilitation; MS gait and balance; deep sensory walkway

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (2)

Classical physical therapy and rehabilitation program

ACTIVE COMPARATOR

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

Other: classical rehabilitation

Deep sensory asisted therapy and rehabilitation program

EXPERIMENTAL

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

Other: Deep sensory assisted rehabilitation

Interventions

classical rehabilitation 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)

Classical physical therapy and rehabilitation program

Deep sensory assisted rehabilitation 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.

Deep sensory asisted therapy and rehabilitation program

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with multiple sclerosis
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bursa Sevket Yilmaz Training and Research Hospital: collaborator
• Nermin Çalışır: lead

Study Sites (2)

University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Yildirim, Turkey (Türkiye)

Location

Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital

Bursa, 16030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• NERMİN ÇALIŞIR

  ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

  STUDY CHAIR

• NURTEN KÜÇÜKÇAKIR

  ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL

  STUDY DIRECTOR

• MERAL SEFEROĞLU

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY DIRECTOR

• ALİ ÖZHAN SIVACI

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal İnvestigator,Head of Neurology

Model Details: classic rehabilitation group vs.deep sensory assisted rehabilitation group

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

TU (2)