Multiple SclerosisNCT05937971
Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)
A study testing plantar sensitivity training and aerobic exercise training in people with Multiple Sclerosis, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- plantar sensitivity training and aerobic exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Arel University
Istanbul, Zeytinburnu, 34010
NAZLI GÜNGÖR, PT,MSc, +90 5398659517, nazligungor@arel.edu.tr
About this 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
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.
Read more
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- plantar sensitivity training, aerobic exercise training
- Keywords
- multiple sclerosis, plantar sensitivity, plantar sensitivity training, aerobic training, clinical trial, balance, gait, functional capacity, proprioception
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar sensitivity trainingOther
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)
aerobic exercise trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| plantar sensitivity training group | Experimental | 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. Receives: Other: plantar sensitivity training; Other: aerobic exercise training |
| aerobic exercise training group | Active comparator | 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. Receives: Other: aerobic exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance measurement (One-leg standing test(seconds))
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.
Measured: 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)
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.
Measured: Change from before treatment at 12 weeks of intervention/treatment
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.
Measured: 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)
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.
Measured: Change from before treatment at 12 weeks of intervention/treatment
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.
Measured: Change from before treatment at 12 weeks of intervention/treatment
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.
Measured: Change from before treatment at 12 weeks of intervention/treatment
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.
Measured: Change from before treatment at 12 weeks of intervention/treatment
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.
Measured: 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)
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.
Measured: Change from before treatment at 12 weeks of intervention/treatment
Secondary outcomes (3)
functional capacity measurement
6-minute walk test
Measured: Change from before treatment at 12 weeks of intervention/treatment
proprioception measurement (-Ankle position sensation)
Passive motion detection threshold test will be performed with a digital goniometer.
Measured: Change from before treatment at 12 weeks of intervention/treatment
proprioception measurement (-Sensation of ankle kinesthesia)
Joint position reproduction test will be performed with a digital goniometer.
Measured: Change from before treatment at 12 weeks of intervention/treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 Sep 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, NAZLI GÜNGÖR, Istanbul Arel University
- Investigators
- Nazlı Güngör, PT, MSc, Principal investigator, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937971
- Sponsor's protocol ID
- PlaSTAcET
- Status last verified
- Sep 2023
- First submitted
- 20 May 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Homayuni A, Hosseini Z. Correction: An intervention design for promoting quality of life among patients with multiple sclerosis: a protocol with a planning approach for a mixed methods study. BMC Neurol. 2023 Feb 6;23(1):61. doi: 10.1186/s12883-023-03103-y. No abstract available.
PubMed 36747125Monaghan AS, Huisinga JM, Peterson DS. The relationship between plantar sensation and muscle onset during automatic postural responses in people with multiple sclerosis and healthy controls. Mult Scler Relat Disord. 2021 Nov;56:103313. doi: 10.1016/j.msard.2021.103313. Epub 2021 Oct 5.
PubMed 34644600Song Q, Zhang X, Mao M, Sun W, Zhang C, Chen Y, Li L. Relationship of proprioception, cutaneous sensitivity, and muscle strength with the balance control among older adults. J Sport Health Sci. 2021 Sep;10(5):585-593. doi: 10.1016/j.jshs.2021.07.005. Epub 2021 Jul 20.
PubMed 34293496Peebles AT, Bruetsch AP, Lynch SG, Huisinga JM. Dynamic Balance Is Related to Physiological Impairments in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2030-2037. doi: 10.1016/j.apmr.2017.11.010. Epub 2017 Dec 22.
PubMed 29274726Kalron A, Pasitselsky D, Greenberg-Abrahami M, Achiron A. Do textured insoles affect postural control and spatiotemporal parameters of gait and plantar sensation in people with multiple sclerosis? PM R. 2015 Jan;7(1):17-25. doi: 10.1016/j.pmrj.2014.08.942. Epub 2014 Aug 19.
PubMed 25153447Naka T, Hayashi T, Sugyo A, Watanabe R, Towatari F, Maeda T. The effects of lower extremity deep sensory impairments on walking capability in patients with incomplete cervical spinal cord injury. J Spinal Cord Med. 2022 Mar;45(2):287-292. doi: 10.1080/10790268.2020.1788879. Epub 2020 Jul 23.
PubMed 32701408Parsons SL, Mansfield A, Inness EL, Patterson KK. The relationship of plantar cutaneous sensation and standing balance post-stroke. Top Stroke Rehabil. 2016 Oct;23(5):326-32. doi: 10.1080/10749357.2016.1162396. Epub 2016 Mar 31.
PubMed 27077993Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
PubMed 29740561Chisholm AE, Qaiser T, Williams AMM, Eginyan G, Lam T. Acquisition of a precision walking skill and the impact of proprioceptive deficits in people with motor-incomplete spinal cord injury. J Neurophysiol. 2019 Mar 1;121(3):1078-1084. doi: 10.1152/jn.00432.2018. Epub 2019 Feb 6.
PubMed 30726165Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
PubMed 25739555Van Geel F, Bielen H, Theunissen K, Moumdjian L, Van Nieuwenhoven J, Van Wijmeersch B, Meesen R, Ramari C, Feys P. Clinical manifestation and perceived symptoms of walking-related performance fatigability in persons with multiple sclerosis. Int J Rehabil Res. 2021 Jun 1;44(2):118-125. doi: 10.1097/MRR.0000000000000457.
PubMed 33534273Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
PubMed 23669008Dixit S, Maiya A, Shastry BA. Effects of Aerobic Exercise on Vibration Perception Threshold in Type 2 Diabetic Peripheral Neuropathy Population Using 3-sites Method: Single-blind Randomized Controlled Trial. Altern Ther Health Med. 2019 Mar;25(2):36-41.
PubMed 30990792Burcal CJ, Wikstrom EA. Plantar Cutaneous Sensitivity With and Without Cognitive Loading in People With Chronic Ankle Instability, Copers, and Uninjured Controls. J Orthop Sports Phys Ther. 2016 Apr;46(4):270-6. doi: 10.2519/jospt.2016.6351. Epub 2016 Jan 26.
PubMed 26813754Chetta A, Zanini A, Pisi G, Aiello M, Tzani P, Neri M, Olivieri D. Reference values for the 6-min walk test in healthy subjects 20-50 years old. Respir Med. 2006 Sep;100(9):1573-8. doi: 10.1016/j.rmed.2006.01.001. Epub 2006 Feb 7.
PubMed 16466676
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05937971
- Acronym / sponsor ID
- PlaSTAcET
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, plantar sensitivity, plantar sensitivity training, aerobic training, clinical trial, balance, gait, functional capacity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| plantar sensitivity training group | Experimental | Other: plantar sensitivity training, Other: aerobic exercise trainingConventional 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. |
| aerobic exercise training group | Active comparator | Other: aerobic exercise trainingConventional 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plantar sensitivity trainingPlantar 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 | plantar sensitivity training group |
| aerobic exercise trainingWarm-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. | Other | aerobic exercise training group, plantar sensitivity training group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
functional capacity measurement
Time frame: 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
proprioception measurement (-Sensation of ankle kinesthesia)
Time frame: Change from before treatment at 12 weeks of intervention/treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 36747125Homayuni A, Hosseini Z. Correction: An intervention design for promoting quality of life among patients with multiple sclerosis: a protocol with a planning approach for a mixed methods study. BMC Neurol. 2023 Feb 6;23(1):61. doi: 10.1186/s12883-023-03103-y. No abstract available.
- Results publication: PubMed 34644600Monaghan AS, Huisinga JM, Peterson DS. The relationship between plantar sensation and muscle onset during automatic postural responses in people with multiple sclerosis and healthy controls. Mult Scler Relat Disord. 2021 Nov;56:103313. doi: 10.1016/j.msard.2021.103313. Epub 2021 Oct 5.
- Results publication: PubMed 34293496Song Q, Zhang X, Mao M, Sun W, Zhang C, Chen Y, Li L. Relationship of proprioception, cutaneous sensitivity, and muscle strength with the balance control among older adults. J Sport Health Sci. 2021 Sep;10(5):585-593. doi: 10.1016/j.jshs.2021.07.005. Epub 2021 Jul 20.
- Results publication: PubMed 29274726Peebles AT, Bruetsch AP, Lynch SG, Huisinga JM. Dynamic Balance Is Related to Physiological Impairments in Persons With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2030-2037. doi: 10.1016/j.apmr.2017.11.010. Epub 2017 Dec 22.
- Results publication: PubMed 25153447Kalron A, Pasitselsky D, Greenberg-Abrahami M, Achiron A. Do textured insoles affect postural control and spatiotemporal parameters of gait and plantar sensation in people with multiple sclerosis? PM R. 2015 Jan;7(1):17-25. doi: 10.1016/j.pmrj.2014.08.942. Epub 2014 Aug 19.
- Results publication: PubMed 32701408Naka T, Hayashi T, Sugyo A, Watanabe R, Towatari F, Maeda T. The effects of lower extremity deep sensory impairments on walking capability in patients with incomplete cervical spinal cord injury. J Spinal Cord Med. 2022 Mar;45(2):287-292. doi: 10.1080/10790268.2020.1788879. Epub 2020 Jul 23.
- Results publication: PubMed 27077993Parsons SL, Mansfield A, Inness EL, Patterson KK. The relationship of plantar cutaneous sensation and standing balance post-stroke. Top Stroke Rehabil. 2016 Oct;23(5):326-32. doi: 10.1080/10749357.2016.1162396. Epub 2016 Mar 31.
- Results publication: PubMed 29740561Khalifeloo M, Naghdi S, Ansari NN, Akbari M, Jalaie S, Jannat D, Hasson S. A study on the immediate effects of plantar vibration on balance dysfunction in patients with stroke. J Exerc Rehabil. 2018 Apr 26;14(2):259-266. doi: 10.12965/jer.1836044.022. eCollection 2018 Apr.
- Results publication: PubMed 30726165Chisholm AE, Qaiser T, Williams AMM, Eginyan G, Lam T. Acquisition of a precision walking skill and the impact of proprioceptive deficits in people with motor-incomplete spinal cord injury. J Neurophysiol. 2019 Mar 1;121(3):1078-1084. doi: 10.1152/jn.00432.2018. Epub 2019 Feb 6.
- Results publication: PubMed 25739555Langeskov-Christensen M, Heine M, Kwakkel G, Dalgas U. Aerobic capacity in persons with multiple sclerosis: a systematic review and meta-analysis. Sports Med. 2015 Jun;45(6):905-23. doi: 10.1007/s40279-015-0307-x.
- Results publication: PubMed 33534273Van Geel F, Bielen H, Theunissen K, Moumdjian L, Van Nieuwenhoven J, Van Wijmeersch B, Meesen R, Ramari C, Feys P. Clinical manifestation and perceived symptoms of walking-related performance fatigability in persons with multiple sclerosis. Int J Rehabil Res. 2021 Jun 1;44(2):118-125. doi: 10.1097/MRR.0000000000000457.
- Results publication: PubMed 23669008Latimer-Cheung AE, Pilutti LA, Hicks AL, Martin Ginis KA, Fenuta AM, MacKibbon KA, Motl RW. Effects of exercise training on fitness, mobility, fatigue, and health-related quality of life among adults with multiple sclerosis: a systematic review to inform guideline development. Arch Phys Med Rehabil. 2013 Sep;94(9):1800-1828.e3. doi: 10.1016/j.apmr.2013.04.020. Epub 2013 May 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazlı Güngör, PT, MSc principal investigator
Istanbul Arel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plantar sensitivity training and aerobic exercise training in people with Multiple Sclerosis, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazlı Güngör, PT, MSc (+905398659517, nazligungor@arel.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance measurement (One-leg standing test(seconds)) (time frame: Change from before treatment at 12 weeks of intervention/treatment). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937971, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.