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

NCT05937971 | Unknown

• 1 other identifier: PlaSTAcET
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; plantar sensitivity; plantar sensitivity training; aerobic training; clinical trial; balance; gait; functional capacity; proprioception

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Change from before treatment at 12 weeks of intervention/treatment

Secondary Outcomes (3)

• functional capacity measurement

  Change from before treatment at 12 weeks of intervention/treatment

• proprioception measurement (-Ankle position sensation)

  Change from before treatment at 12 weeks of intervention/treatment

• proprioception measurement (-Sensation of ankle kinesthesia)

  Change from before treatment at 12 weeks of intervention/treatment

Other Outcomes (1)

• plantar sensitivity measurement

  Change from before treatment at 12 weeks of intervention/treatment

Study Arms (2)

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.

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.

Other: aerobic exercise training

Interventions

plantar sensitivity training OTHER

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)

plantar sensitivity training group

aerobic exercise training OTHER

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.

aerobic exercise training group; plantar sensitivity training group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• for 2-3rd metatarsal heads;
• for 4-5th metatarsal heads;
• for the lateral and medial heel)(15)
• Decreased functional capacity (6-minute walking test distance F\<593±57meters, M\<638±44meters) (16)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Arel University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (1)

Istanbul Arel University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

RECRUITING

Related Publications (16)

• 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.

  PMID: 36747125 RESULT

• Monaghan 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.

  PMID: 34644600 RESULT

• Song 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.

  PMID: 34293496 RESULT

• Peebles 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.

  PMID: 29274726 RESULT

• Kalron 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.

  PMID: 25153447 RESULT

• Naka 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.

  PMID: 32701408 RESULT

• Parsons 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.

  PMID: 27077993 RESULT

• Khalifeloo 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.

  PMID: 29740561 RESULT

• Chisholm 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.

  PMID: 30726165 RESULT

• Langeskov-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.

  PMID: 25739555 RESULT

• Van 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.

  PMID: 33534273 RESULT

• Latimer-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.

  PMID: 23669008 RESULT

• Dixit 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.

  PMID: 30990792 RESULT

• Burcal 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.

  PMID: 26813754 RESULT

• Chetta 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.

  PMID: 16466676 RESULT

• Vaitkus A, Sipylaite J. Sensory Perception in Lumbosacral Radiculopathy with Radicular Pain: Feasibility Study of Multimodal Bedside-Suitable Somatosensory Testing. Acta Med Litu. 2021;28(1):97-111. doi: 10.15388/Amed.2021.28.1.18. Epub 2021 Apr 29.

  PMID: 34393632 RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nazlı Güngör, PT, MSc

  Istanbul Arel University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazlı Güngör, PT, MSc

CONTACT

+905398659517; nazligungor@arel.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: July 10, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)