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

Primary Purpose

MS (Multiple Sclerosis)

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Deep sensory assisted rehabilitation
classical rehabilitation
Sponsored by
Nermin Çalışır
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MS (Multiple Sclerosis) focused on measuring deep sensory assisted rehabilitation, MS gait and balance, deep sensory walkway

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
  • Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Classical physical therapy and rehabilitation program

Deep sensory asisted therapy and rehabilitation program

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 26, 2023
Last Updated
August 7, 2023
Sponsor
Nermin Çalışır
Collaborators
Bursa Sevket Yilmaz Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05991297
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nermin Çalışır
Collaborators
Bursa Sevket Yilmaz Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MS (Multiple Sclerosis)
Keywords
deep sensory assisted rehabilitation, MS gait and balance, deep sensory walkway

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
classic rehabilitation group vs.deep sensory assisted rehabilitation group
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Classical physical therapy and rehabilitation program
Arm Type
Active Comparator
Arm Description
Classical rehabilitation program (stretching, strenght, balance and coordination exercise) for fifty minutes.
Arm Title
Deep sensory asisted therapy and rehabilitation program
Arm Type
Experimental
Arm Description
Deep sensory asisted rehabilitation program (stretching, strenght, balance and coordination and deep sensory exercises) for fifty minutes.
Intervention Type
Other
Intervention Name(s)
Deep sensory assisted rehabilitation
Intervention Description
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
Intervention Name(s)
classical rehabilitation
Intervention 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)
Primary Outcome Measure Information:
Title
Multipl sclerosis quality of life-54(MSQOL-54)
Description
: 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.
Time Frame
1st day: when rehabilitation applications started
Title
Multipl sclerosis quality of life-54(MSQOL-54)
Description
: 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.
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
MiniBest test
Description
minimum and maximum score: 0-28: high score indicates good functional balance
Time Frame
1st day: when rehabilitation applications started
Title
MiniBest test
Description
minimum and maximum score: 0-28: high score indicates good functional balance
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
10 meter walking time
Description
The patient's walking time of the determined 10-meter distance is measured.
Time Frame
1st day: when rehabilitation applications started
Title
10 meter walking time
Description
The patient's walking time of the determined 10-meter distance is measured.
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
Nottingham Extended Activities of Daily Living Scale
Description
minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
Time Frame
1st day: when rehabilitation applications started
Title
Nottingham Extended Activities of Daily Living Scale
Description
minimum and maximum score: 0-66: high score indicates no restriction in activities of daily living.
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
Functional Ambulation Classification
Description
minimum and maximum score :0-5: high score indicates that walking can be done independently.
Time Frame
1st day: when rehabilitation applications started
Title
Functional Ambulation Classification
Description
minimum and maximum score :0-5: high score indicates that walking can be done independently.
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
Fatigue Severity Score
Description
A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
Time Frame
1st day: when rehabilitation applications started
Title
Fatigue Severity Score
Description
A score lower than 2.8 indicates no fatigue, a score higher than 6.1 indicates chronic fatigue
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
DN4(Douleur Neuropathique 4 Questions)
Description
Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
Time Frame
1st day: when rehabilitation applications started
Title
DN4(Douleur Neuropathique 4 Questions)
Description
Minimum and maximum score: 0-10: A score of 4 and above indicates neuropathic pain.
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
MSWS-12( MS walking scale-12)
Description
minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
Time Frame
1st day: when rehabilitation applications started
Title
MSWS-12( MS walking scale-12)
Description
minimum and maximum scores: 12-54: low scores indicate that gait disturbance has little effect on disability.
Time Frame
after 7 weeks: when rehabilitation applications ended
Title
FES-1: (Falls Efficay Scale-1)
Description
minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
Time Frame
1st day: when rehabilitation applications started
Title
FES-1: (Falls Efficay Scale-1)
Description
minimum and maximum score: 16-64: higher score indicates increased anxiety about falling
Time Frame
after 7 weeks: when rehabilitation applications ended

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NERMİN ÇALIŞIR
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
NURTEN KÜÇÜKÇAKIR
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
MERAL SEFEROĞLU
Organizational Affiliation
UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
ALİ ÖZHAN SIVACI
Organizational Affiliation
UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
CELAL BATUHAN GÜNEYSU
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İSMAİL HACIOĞLU
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YUSUF ZİYA ŞAHİN
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MUHAMMED SOC HASANOĞLU
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
MAHMUT CAN ERDOĞAN
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SİNAN ATİLLA
Organizational Affiliation
ROMATEM PHYSICAL THERAPY AND REHABILITATION HOSPITALS BURSA HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
State/Province
Yildirim
Country
Turkey
Facility Name
Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital
City
Bursa
ZIP/Postal Code
16030
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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