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Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
plantar sensitivity training
aerobic exercise training
Sponsored by
Istanbul Arel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, plantar sensitivity, plantar sensitivity training, aerobic training, clinical trial, balance, gait, functional capacity, proprioception

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: being between the ages of 18-65 Being diagnosed with multiple sclerosis according to McDonald's criteria EDSS (Expanded Disability Status Scale) score between 3 and 5.5 Stage 3/4/5 according to functional ambulation classification Being able to ambulatory 100 meters independently or with device assistance Not having an attack in the last 3 months No change in routine treatment for MS (multiple sclerosis) in the past 3 months Presence of plantar sensitivity loss (as measured with Semmes-Weinstein monofilaments) having a plantar sensory threshold value higher than 2,83-3.61 for 1st metatarsal head; 2.83-3.61 for 2-3rd metatarsal heads; 2.83-3.61 for 4-5th metatarsal heads; 3.61-4.08 for the lateral and medial heel)(15) Decreased functional capacity (6-minute walking test distance F<593Β±57meters, M<638Β±44meters) (16) Exclusion Criteria: Being diagnosed with pulmonary, orthopedic or cardiovascular disease having diabetic neuropathy Having neurological disease other than multiple sclerosis Having a diagnosis of root compression, radiculopathy, lumbar disc herniation or complaining of low back pain for the last 3 months(17) Using an ankle-foot orthosis (AFO) Having cognitive dysfunction (MoCA score <21)

Sites / Locations

  • Istanbul Arel UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

plantar sensitivity training group

aerobic exercise training group

Arm Description

Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients.

Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients.

Outcomes

Primary Outcome Measures

Balance measurement (One-leg standing test(seconds))
The participant will be asked to stand on one leg while the other's knee is in 90Β° flexion. The stopwatch will be recorded time in seconds. The test will be terminated if the subject's upper foot touches the ground. Separate measurements are made for both extremities.
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry) -Bipedal 30 seconds oscillation amplitude (mm)
This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be recorded and it demonstrates the sum of deviations from the center of mass.
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Maximum oscillating amplitude (mm)
This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be measured and the maximum deviation from the center of mass will be recorded.
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Average oscillation rate (mm/s)
This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be measured and the average deviation rate from the center of mass will be recorded.
gait measurement (-timed 25-foot walk test)
The T25-FW (timed 25-foot walk test) is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC (Multiple Sclerosis Functional Composite) to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
gait measurement(spatiotemporal parameters of gait (with baropodometry) -stride length (mm))
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. Stride length will be measured and recorded.
gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral maximum pressure (gr/cm2)
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. The maximum pressure of both feet will be separately measured and recorded.
gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral mean pressure (gr/cm2)
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. The average pressure of both feet will be separately measured and recorded.
gait measurement (spatiotemporal parameters of gait (with baropodometry) -Right-left load distribution (%) (from five different points: 1st metatarsal head, 2nd-3rd metatarsal head, 4th-5th metatarsal head, heel medial, heel lateral)
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. Right-left foot load distribution from five different points (1st metatarsal head, 2nd-3rd metatarsal head, 4th-5th metatarsal head, heel medial, heel lateral) will be separately measured and recorded.

Secondary Outcome Measures

functional capacity measurement
6-minute walk test
proprioception measurement (-Ankle position sensation)
Passive motion detection threshold test will be performed with a digital goniometer.
proprioception measurement (-Sensation of ankle kinesthesia)
Joint position reproduction test will be performed with a digital goniometer.

Full Information

First Posted
May 20, 2023
Last Updated
September 26, 2023
Sponsor
Istanbul Arel University
Collaborators
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05937971
Brief Title
Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)
Official Title
Examination of the Implications of Plantar Sensitivity Training and Aerobic Exercise Training on Balance, Functional Capacity, Gait and Proprioception in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Arel University
Collaborators
Istanbul University - Cerrahpasa (IUC)

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 aim of this thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis. In this direction, the hypotheses of the study are stated below. H0 hypothesis: Plantar sensory training given in addition to aerobic exercise training in patients with multiple sclerosis has no additional contribution to balance, functional capacity, walking and proprioception. H1 hypothesis: Plantar sensory training given in addition to aerobic exercise training in patients with multiple sclerosis has an additional contribution to balance, functional capacity, walking and proprioception. Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients. As a result of the study, it will be examined whether plantar sensory training given in addition to aerobic exercise training in multiple sclerosis patients has an additional contribution to balance, functional capacity, walking and proprioception. There is no study in the literature examining the effects of plantar sensory training and aerobic exercise training on balance, functional capacity, walking and proprioception in patients with multiple sclerosis. In this respect, it is anticipated that the study will contribute to the literature.
Detailed Description
The aim of this thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis. Multiple sclerosis is a chronic progressive neurodegenerative disease that causes damage to neural structures such as myelin sheath, oligodendrocytes, and axons in the central nervous system. In addition to motor, cognitive, cerebellar, visual and brain stem functions, sensory functions are also affected in patients with multiple sclerosis. Loss of deep and superficial senses, dysesthesia and paresthesias can be given as examples of these sensory dysfunctions. It is known that plantar cutaneous sensory information provides important clues in maintaining balance, and disturbances in sensory information for any reason cause postural oscillations. Therefore, it is thought that sensory dysfunction in patients with multiple sclerosis may be related to deficits in maintaining static and dynamic balance. There are limited studies on the positive effects of plantar sensory manipulations on balance in different patient populations. The decrease in aerobic capacity in patients with multiple sclerosis may affect parameters such as balance, walking, and sensory functions. Due to these effects, activity limitations, decreased walking distance, falls, and injuries related to falling may occur in patients. It has been shown that aerobic exercise training increases functional capacity in patients with multiple sclerosis and deep senses such as proprioception and vibration in different patient groups. In this direction, the aim of the thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis. There is no study in the literature examining the effects of plantar sensory training and aerobic exercise training on balance, functional capacity, walking and proprioception in patients with multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, plantar sensitivity, plantar sensitivity training, aerobic training, clinical trial, balance, gait, functional capacity, proprioception

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
plantar sensitivity training group
Arm Type
Experimental
Arm Description
Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients.
Arm Title
aerobic exercise training group
Arm Type
Active Comparator
Arm Description
Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients.
Intervention Type
Other
Intervention Name(s)
plantar sensitivity training
Intervention Description
Plantar sensory training protocol: Applying a moisturizing cream by washing the feet with warm water and drying them (before coming to the session) Dynamic gastro-soleus stretching (20 sec, 5 reps, 2 min) Plantar fascia stretch (20 sec, 5 reps, 2 min) Picking up sheets with feet (10 reps, 2 min) Pushing the small roller under the foot back and forth (10 reps, 2 min) Holding the spiny proprioception ball on the plantar surface of the foot while sitting, moving it in anterior-posterior and circular directions (2x2.5 min=5 min) Keeping the carpet pieces of different softness and texture on the plantar surface of the foot and moving them in anterior-posterior and circular directions (2x2.5 min=5 min) Soft tissue mobilizations applied to the soles of the feet by the physiotherapist (2 minutes)
Intervention Type
Other
Intervention Name(s)
aerobic exercise training
Intervention Description
Warm-up exercises; will consist of stretching exercises (20-30 s, 5 repetitions), breathing exercises (6-10 s, 5 repetitions) and range of motion exercises (8-10 s, 5 repetitions) for the whole body. Conventional exercises will include balance (10 s, 5 reps), coordination (5-10 s, 5 reps), stabilization (5-10 s, 5 reps) and strengthening exercises (8-10 s, 5 reps), specific to each patient. Aerobic exercise training was started at 40% of the maximum heart rate on the treadmill and gradually increased at three-week intervals (40% in weeks 1-3, 50% in weeks 4-6, 60% in weeks 7-9, and 70% in weeks 10-12). ) will be progressed. Cool-down exercises will include a gradual lowering of the treadmill speed (3 min) and ankle range of motion exercises. Plantar sensory training begins with a duration of 5 minutes and progresses from a sitting position to a standing position at three-week intervals (1-3 weeks 5 minutes, 4-6 weeks 10 minutes, 7-9 weeks 15 minutes, 10-12 weeks 20 minutes). will be.
Primary Outcome Measure Information:
Title
Balance measurement (One-leg standing test(seconds))
Description
The participant will be asked to stand on one leg while the other's knee is in 90Β° flexion. The stopwatch will be recorded time in seconds. The test will be terminated if the subject's upper foot touches the ground. Separate measurements are made for both extremities.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry) -Bipedal 30 seconds oscillation amplitude (mm)
Description
This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be recorded and it demonstrates the sum of deviations from the center of mass.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Maximum oscillating amplitude (mm)
Description
This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be measured and the maximum deviation from the center of mass will be recorded.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Average oscillation rate (mm/s)
Description
This measurement will be performed with a baropodometry. The patient is asked to stand on the baropodometry platform surface with both feet. Postural sways will be measured and the average deviation rate from the center of mass will be recorded.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
gait measurement (-timed 25-foot walk test)
Description
The T25-FW (timed 25-foot walk test) is a quantitative mobility and leg function performance test based on a timed 25-walk. It is the first component of the MSFC (Multiple Sclerosis Functional Composite) to be administered at each visit. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The time is calculated from the initiation of the instruction to start and ends when the patient has reached the 25-foot mark. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
gait measurement(spatiotemporal parameters of gait (with baropodometry) -stride length (mm))
Description
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. Stride length will be measured and recorded.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral maximum pressure (gr/cm2)
Description
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. The maximum pressure of both feet will be separately measured and recorded.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral mean pressure (gr/cm2)
Description
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. The average pressure of both feet will be separately measured and recorded.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
gait measurement (spatiotemporal parameters of gait (with baropodometry) -Right-left load distribution (%) (from five different points: 1st metatarsal head, 2nd-3rd metatarsal head, 4th-5th metatarsal head, heel medial, heel lateral)
Description
This measurement will be performed with a baropodometry. The patient is asked to walk on the baropodometry platform surface. Right-left foot load distribution from five different points (1st metatarsal head, 2nd-3rd metatarsal head, 4th-5th metatarsal head, heel medial, heel lateral) will be separately measured and recorded.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Secondary Outcome Measure Information:
Title
functional capacity measurement
Description
6-minute walk test
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
proprioception measurement (-Ankle position sensation)
Description
Passive motion detection threshold test will be performed with a digital goniometer.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Title
proprioception measurement (-Sensation of ankle kinesthesia)
Description
Joint position reproduction test will be performed with a digital goniometer.
Time Frame
Change from before treatment at 12 weeks of intervention/treatment
Other Pre-specified Outcome Measures:
Title
plantar sensitivity measurement
Description
from 1st metatarsal head, 2nd-3rd. metatarsal head, 4-5. metatarsal head, medial calcaneus, lateral calcaneus points (with Semmes-Weinstein monofilaments)
Time Frame
Change from before treatment at 12 weeks of intervention/treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: being between the ages of 18-65 Being diagnosed with multiple sclerosis according to McDonald's criteria EDSS (Expanded Disability Status Scale) score between 3 and 5.5 Stage 3/4/5 according to functional ambulation classification Being able to ambulatory 100 meters independently or with device assistance Not having an attack in the last 3 months No change in routine treatment for MS (multiple sclerosis) in the past 3 months Presence of plantar sensitivity loss (as measured with Semmes-Weinstein monofilaments) having a plantar sensory threshold value higher than 2,83-3.61 for 1st metatarsal head; 2.83-3.61 for 2-3rd metatarsal heads; 2.83-3.61 for 4-5th metatarsal heads; 3.61-4.08 for the lateral and medial heel)(15) Decreased functional capacity (6-minute walking test distance F<593Β±57meters, M<638Β±44meters) (16) Exclusion Criteria: Being diagnosed with pulmonary, orthopedic or cardiovascular disease having diabetic neuropathy Having neurological disease other than multiple sclerosis Having a diagnosis of root compression, radiculopathy, lumbar disc herniation or complaining of low back pain for the last 3 months(17) Using an ankle-foot orthosis (AFO) Having cognitive dysfunction (MoCA score <21)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NazlΔ± GΓΌngΓΆr, PT, MSc
Phone
+905398659517
Email
nazligungor@arel.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NazlΔ± GΓΌngΓΆr, PT, MSc
Organizational Affiliation
Istanbul Arel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Arel University
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NAZLI GÜNGΓ–R, PT,MSc
Phone
+90 5398659517
Email
nazligungor@arel.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)

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