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

Sponsor

Istanbul Arel University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05937971

Collaborator

Istanbul University - Cerrahpasa (IUC) (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Other: plantar sensitivity training Other: aerobic exercise training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized controlled trialrandomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: plantar sensitivity training group 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.	Other: plantar sensitivity training 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) Other: aerobic exercise training 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.
Active Comparator: aerobic exercise training group 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.	Other: aerobic exercise training 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.

Arm

Intervention/Treatment

Experimental: plantar sensitivity training group

Other: plantar sensitivity training

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)

Other: aerobic exercise training

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.

Active Comparator: aerobic exercise training group

Other: aerobic exercise training

Outcome Measures

Primary Outcome Measures

Balance measurement (One-leg standing test(seconds)) [Change from before treatment at 12 weeks of intervention/treatment]
The participant will be asked to stand on one leg while the other's knee is in 90° 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) [Change from before treatment at 12 weeks of intervention/treatment]
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) [Change from before treatment at 12 weeks of intervention/treatment]
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) [Change from before treatment at 12 weeks of intervention/treatment]
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) [Change from before treatment at 12 weeks of intervention/treatment]
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)) [Change from before treatment at 12 weeks of intervention/treatment]
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) [Change from before treatment at 12 weeks of intervention/treatment]
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) [Change from before treatment at 12 weeks of intervention/treatment]
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) [Change from before treatment at 12 weeks of intervention/treatment]
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 [Change from before treatment at 12 weeks of intervention/treatment]
6-minute walk test
proprioception measurement (-Ankle position sensation) [Change from before treatment at 12 weeks of intervention/treatment]
Passive motion detection threshold test will be performed with a digital goniometer.
proprioception measurement (-Sensation of ankle kinesthesia) [Change from before treatment at 12 weeks of intervention/treatment]
Joint position reproduction test will be performed with a digital goniometer.

Other Outcome Measures

plantar sensitivity measurement [Change from before treatment at 12 weeks of intervention/treatment]
from 1st metatarsal head, 2nd-3rd. metatarsal head, 4-5. metatarsal head, medial calcaneus, lateral calcaneus points (with Semmes-Weinstein monofilaments)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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<593±57meters, M<638±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)