Clinical trial NCT05937971: Plantar Sensitivity Training and Aerobic Exercise Training in Patients With Multiple Sclerosis (PlaSTAcET Study)
Official title: Examination of the Implications of Plantar Sensitivity Training and Aerobic Exercise Training on Balance, Functional Capacity, Gait and Proprioception in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
plantar sensitivity
plantar sensitivity training
aerobic training
clinical trial
balance
gait
functional capacity
proprioception
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2023-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The aim of this thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis. In this direction, the hypotheses of the study are stated below.

H0 hypothesis: Plantar sensory training given in addition to aerobic exercise training in patients with multiple sclerosis has no additional contribution to balance, functional capacity, walking and proprioception.

H1 hypothesis: Plantar sensory training given in addition to aerobic exercise training in patients with multiple sclerosis has an additional contribution to balance, functional capacity, walking and proprioception.

Conventional exercises (with the addition of warm-up and cool-down periods) will be applied to all multiple sclerosis patients participating in the study; In addition, aerobic exercise training will be given. In addition to these exercises, plantar sensory training will be given to the sensory training group. Exercises and plantar sensory training will be given to the participants at intervals of three weeks, with progressively progressive sessions, 2 days a week for 12 weeks. Patients will be evaluated twice, before treatment and at the end of treatment 12 weeks later. Within the scope of the evaluation, balance, functional capacity, gait, proprioception and plantar sensory parameters will be measured in patients. As a result of the study, it will be examined whether plantar sensory training given in addition to aerobic exercise training in multiple sclerosis patients has an additional contribution to balance, functional capacity, walking and proprioception. There is no study in the literature examining the effects of plantar sensory training and aerobic exercise training on balance, functional capacity, walking and proprioception in patients with multiple sclerosis. In this respect, it is anticipated that the study will contribute to the literature.

Detailed description: The aim of this thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis.

Multiple sclerosis is a chronic progressive neurodegenerative disease that causes damage to neural structures such as myelin sheath, oligodendrocytes, and axons in the central nervous system. In addition to motor, cognitive, cerebellar, visual and brain stem functions, sensory functions are also affected in patients with multiple sclerosis. Loss of deep and superficial senses, dysesthesia and paresthesias can be given as examples of these sensory dysfunctions. It is known that plantar cutaneous sensory information provides important clues in maintaining balance, and disturbances in sensory information for any reason cause postural oscillations. Therefore, it is thought that sensory dysfunction in patients with multiple sclerosis may be related to deficits in maintaining static and dynamic balance. There are limited studies on the positive effects of plantar sensory manipulations on balance in different patient populations.

The decrease in aerobic capacity in patients with multiple sclerosis may affect parameters such as balance, walking, and sensory functions. Due to these effects, activity limitations, decreased walking distance, falls, and injuries related to falling may occur in patients. It has been shown that aerobic exercise training increases functional capacity in patients with multiple sclerosis and deep senses such as proprioception and vibration in different patient groups. In this direction, the aim of the thesis study is to examine whether plantar sensory training given in addition to aerobic exercise training has an additional contribution to balance, functional capacity, walking and proprioception in patients with multiple sclerosis.

There is no study in the literature examining the effects of plantar sensory training and aerobic exercise training on balance, functional capacity, walking and proprioception in patients with multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* being between the ages of 18-65
* Being diagnosed with multiple sclerosis according to McDonald's criteria
* EDSS (Expanded Disability Status Scale) score between 3 and 5.5
* Stage 3/4/5 according to functional ambulation classification
* Being able to ambulatory 100 meters independently or with device assistance
* Not having an attack in the last 3 months
* No change in routine treatment for MS (multiple sclerosis) in the past 3 months
* Presence of plantar sensitivity loss (as measured with Semmes-Weinstein monofilaments)

  * having a plantar sensory threshold value higher than 2,83-3.61 for 1st metatarsal head;
  * 2.83-3.61 for 2-3rd metatarsal heads;
  * 2.83-3.61 for 4-5th metatarsal heads;
  * 3.61-4.08 for the lateral and medial heel)(15)
* Decreased functional capacity (6-minute walking test distance F\<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)

Primary outcomes:
measure: Balance measurement (One-leg standing test(seconds))
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry) -Bipedal 30 seconds oscillation amplitude (mm)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Maximum oscillating amplitude (mm)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: Balance measurement (measurement of spatiotemporal parameters of balance (with baropodometry)-Average oscillation rate (mm/s)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: gait measurement (-timed 25-foot walk test)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: gait measurement(spatiotemporal parameters of gait (with baropodometry) -stride length (mm))
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral maximum pressure (gr/cm2)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: gait measurement spatiotemporal parameters of gait (with baropodometry) -Bilateral mean pressure (gr/cm2)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: 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)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
Secondary outcomes:
measure: functional capacity measurement
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: proprioception measurement (-Ankle position sensation)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
measure: proprioception measurement (-Sensation of ankle kinesthesia)
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
Other outcomes:
measure: plantar sensitivity measurement
timeFrame: Change from before treatment at 12 weeks of intervention/treatment
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Arel University
state: Zeytinburnu
Study officials:
affiliation: Istanbul Arel University
name: Nazlı Güngör, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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