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

MS (Multiple Sclerosis) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05991297
• Other study ID #: ROMATEM-NERMIN ÇALISIR 2023
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: August 2023
• Source: Romatem Bursa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• MS (Multiple Sclerosis)
• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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)

Locations

Country	Name	City	State
Turkey	Romatem Physical Therapy and Rehabilitation Hospitals Bursa Hospital	Bursa
Turkey	University of Health Sciences Bursa Yuksek Ihtisas Training and Research Hospital	Bursa	Yildirim

Sponsors (2)

Lead Sponsor	Collaborator
Nermin Çalisir	Bursa Sevket Yilmaz Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	MiniBest test	minimum and maximum score: 0-28: high score indicates good functional balance	1st day: when rehabilitation applications started
Primary	MiniBest test	minimum and maximum score: 0-28: high score indicates good functional balance	after 7 weeks: when rehabilitation applications ended
Primary	10 meter walking time	The patient's walking time of the determined 10-meter distance is measured.	1st day: when rehabilitation applications started
Primary	10 meter walking time	The patient's walking time of the determined 10-meter distance is measured.	after 7 weeks: when rehabilitation applications ended
Primary	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
Primary	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
Primary	Functional Ambulation Classification	minimum and maximum score :0-5: high score indicates that walking can be done independently.	1st day: when rehabilitation applications started
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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