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

September 26, 2023 updated by: NAZLI GÜNGÖR, Istanbul Arel University

Examination of the Implications of Plantar Sensitivity Training and Aerobic Exercise Training on Balance, Functional Capacity, Gait and Proprioception in Patients With Multiple Sclerosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Zeytinburnu
      • Istanbul, Zeytinburnu, Turkey, 34010
        • Recruiting
        • Istanbul Arel University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance measurement (One-leg standing test(seconds))
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry) -Bipedal 30 seconds oscillation amplitude (mm)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Maximum oscillating amplitude (mm)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Average oscillation rate (mm/s)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
gait measurement (-timed 25-foot walk test)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
gait measurement(spatiotemporal parameters of gait (with baropodometry) -stride length (mm))
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral maximum pressure (gr/cm2)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral mean pressure (gr/cm2)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment
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)
Time Frame: 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.
Change from before treatment at 12 weeks of intervention/treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional capacity measurement
Time Frame: Change from before treatment at 12 weeks of intervention/treatment
6-minute walk test
Change from before treatment at 12 weeks of intervention/treatment
proprioception measurement (-Ankle position sensation)
Time Frame: Change from before treatment at 12 weeks of intervention/treatment
Passive motion detection threshold test will be performed with a digital goniometer.
Change from before treatment at 12 weeks of intervention/treatment
proprioception measurement (-Sensation of ankle kinesthesia)
Time Frame: Change from before treatment at 12 weeks of intervention/treatment
Joint position reproduction test will be performed with a digital goniometer.
Change from before treatment at 12 weeks of intervention/treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
plantar sensitivity measurement
Time Frame: 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)
Change from before treatment at 12 weeks of intervention/treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Arel University

Collaborators

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Nazlı Güngör, PT, MSc, Istanbul Arel University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

May 20, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PlaSTAcET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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