Effects of Deep Sensory Assisted Rehabilitation on Gait and Balance in Patients With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05991297

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 2 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Deep sensory assisted rehabilitation

Compared with

  • classical rehabilitation

What it measured

Main measures

  • Multipl sclerosis quality of life-54(MSQOL-54)

    1st day: when rehabilitation applications started

    Quality of life (reported by participants)
  • Multipl sclerosis quality of life-54(MSQOL-54)

    after 7 weeks: when rehabilitation applications ended

    Quality of life (reported by participants)
  • MiniBest test

    1st day: when rehabilitation applications started

    Walking and mobility
  • MiniBest test

    after 7 weeks: when rehabilitation applications ended

    Walking and mobility
  • 10 meter walking time

    1st day: when rehabilitation applications started

    Walking and mobility
  • 10 meter walking time

    after 7 weeks: when rehabilitation applications ended

    Walking and mobility
  • Nottingham Extended Activities of Daily Living Scale

    1st day: when rehabilitation applications started

  • Nottingham Extended Activities of Daily Living Scale

    after 7 weeks: when rehabilitation applications ended

  • Functional Ambulation Classification

    1st day: when rehabilitation applications started

    Walking and mobility
  • Functional Ambulation Classification

    after 7 weeks: when rehabilitation applications ended

    Walking and mobility
  • Fatigue Severity Score

    1st day: when rehabilitation applications started

    Fatigue
  • Fatigue Severity Score

    after 7 weeks: when rehabilitation applications ended

    Fatigue
  • DN4(Douleur Neuropathique 4 Questions)

    1st day: when rehabilitation applications started

    Pain
  • DN4(Douleur Neuropathique 4 Questions)

    after 7 weeks: when rehabilitation applications ended

    Pain
  • MSWS-12( MS walking scale-12)

    1st day: when rehabilitation applications started

    Walking and mobility
  • MSWS-12( MS walking scale-12)

    after 7 weeks: when rehabilitation applications ended

    Walking and mobility
  • FES-1: (Falls Efficay Scale-1)

    1st day: when rehabilitation applications started

    Walking and mobilityMood and sleep
  • FES-1: (Falls Efficay Scale-1)

    after 7 weeks: when rehabilitation applications ended

    Walking and mobilityMood and sleep

Who could take part

MS (type not specified) · 20 to 60 · EDSS 3.0 to 5.5

Show the full criteria

Inclusion criteria

* Diagnosed with multiple sclerosis * 20-60 years old * EDSS between 3.0-5.5 Those with EDSS 0-2.5 and spinal and/or cerebellar involvement * Had the last MS attack at least 3 months ago

Exclusion criteria

* schizoaffective disorder * lower extremity amputation * shortness on one side creating asymmetry in the lower extremities * diabetes mellitus * cognitive impairment (at a level that may interfere with communication)

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The effect of physical therapy and rehabilitation on improving the gait and balance disorders of patients has been proven. FTR applications in MS patients have become routine in developed countries. However, due to the high patient density in our country, FTR cannot be performed at the rate we want due to different reasons such as the inability to separate areas special for MS patients, the lack of special FTR applications for MS patients, and the inability to perform regular FTR follow-ups. Even if FTR is recommended and performed, our patients think that FTR is not very effective due to the above reasons and they do not continue. A team of neurology, physical therapy specialists, and physiotherapists was formed, in-service training was completed and a special rehabilitation program for MS patients was created. First of all, we will apply routine classical FTR to our patients. Sensory and deep sensory disorders, which are more common and severe, especially in the lower extremities, also negatively affect gait and balance. A rehabilitation program was created by adding exercises to improve sensation and deep sense, along with muscle strengthening. The results of the 1st and 21st sessions of the patients in the two groups who underwent classical rehabilitation and deep sensory-assisted rehabilitation will be compared. It was planned to evaluate the gait and balance parameters of the patients as numerical data with clinical scales and the C mill device we used in walking and balance exercises.

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History

    1. Started

      Jun 2023

    2. Main results due

      Feb 2024

    3. Finished

      Jun 2024

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