CompletedNot a drug-phase studyProgressive MSNCT06436131

We could not find results for this trial

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What it found

No result 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

  • In-phase Bilateral Exercise

Compared with

  • Conservative exercises

What it measured

Main measures

  • Symbol Digit Modalities Test

    Baseline (3 weeks) until the end of the Intervention (12 weeks)

    Thinking and memory

Other measures (6)

  • Medical Outcomes Study Short Form 36

    Baseline (3rd week) until the end of the Intervention (12 weeks)

    Pain
  • Modified Fatigue Impact Scale

    Baseline (3rd week) until the end of the Intervention (12 weeks)

    Thinking and memoryFatigue
  • Trail Making Test

    Baseline (3 weeks) until the end of the Intervention (12 weeks)

    Thinking and memory
  • Purdue Pegboard Test

    Baseline (3 weeks) until the end of the Intervention (12 weeks)

    Arm and hand function
  • Timed 25-Foot Walk

    Baseline (3 weeks) until the end of the Intervention (12 weeks)

    Disability progressionWalking and mobility
  • Six Spot Step Test

    Baseline (3 weeks) until the end of the Intervention (12 weeks)

    Thinking and memoryWalking and mobilityPhysical functionSpasticity

Who could take part

Progressive MS · 30 to 70

Inclusion Criteria: * diagnosis of progressive multiple sclerosis (MS) (primary or/and secondary progressive MS) * Expanded Disability Status Scale score between three and six * no relapse within 30 days * aged between 30 and 70 years * Mini Mental State of Examination score between 20 and 30 (mild to no cognitive impairment) Exclusion Criteria: * history of any disease affecting the central nervous system other than MS (e.g., stroke, Parkinson's disease, cerebral palsy) * history of cardiovascular disease (e.g., known aneurism, myocardial infarction, hyper/hypotension, heart failure) * severe orthopaedic disorders (e.g., knee or hip replacement, spondylosurgery, disk herniation, recent bone fracture) * mental disorders (e.g., depression, schizophrenia, bipolar syndrome) * pregnancy during the implementation of the study timeline * hearing impairments (i.e., deafness) * visual deficit (e.g., optic neuritis, blindness, diplopia, glaucoma, blurred vision) * history of epileptic seizures * spasticity level on upper or lower limbs more than 1+ (slight increase in muscle tone) according to Modified Ashworth Scale

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

About this trial

In the sponsor's words

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system. MS, typical presents with progression of clinical symptoms which mainly include motor and cognitive impairment, as well as reduction of patients' quality of life. Exercise is an effective approach in the management of the symptoms in people with progressive MS. Previous studies in healthy and in people with MS, reported a close relationship between cognitive functions and upper limb performance. Since patients with progressive MS facing difficulties with performing complex exercises due to cognitive dysfunctions and given the close relationship between cognitive functions and manual dexterity, a reasonable question arises whether a type of upper limbs exercises with less cognitive demands will improve the information processing speed in people with progressive MS. The aim of the current study is to investigate the effects of in-phase bilateral upper limbs exercises on the information processing speed, in patients with progressive MS, given that in-phase bilateral movements needs less attentional load than the other types of bilateral coordination. The intervention protocol lasted for 12 consecutive weeks (30-60 minutes /session x 3 sessions/week) and included in-phase bilateral exercises of the upper limbs, adapted to different sports activities and to functional training. Results from the statistical analysis indicated improvement of the experimental group compared to the control group, on the information processing speed alongside with improvement of motor skills.

Papers

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History

    1. Started

      Oct 2023

    2. Main results due

      Dec 2023

    3. Finished

      Dec 2023

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