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Completed

NCT Number: NCT04325074

Mental Practice and Manipulative Skills Training in Multiple Sclerosis

Introduction: Multiple sclerosis (MS) is a demyelinating disease of the central nervous system which produces both motor and cognitive dysfunctions. MS causes a decline in the performance of activities of daily living (ADL) due to impairments affecting limb function.

Aim: This pilot study sought to determine whether the use of mental practice (MP) or the combined use of MP and the training of manipulative skills would improve the manipulation motor skills and treatment satisfaction among people with MS.

Methods: The study participants were people with MS. Blinded evaluators performed three assessments for each patient (pre-treatment, post-treatment and at a three month follow up). The patients were divided into three groups with alternate allocation: (A) Mental practice, (B) Mental practice + skills training and (C) Control group.

Keywords: activities of daily living; manual dexterity; mental practice, motor image; multiple sclerosis.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients diagnosed with MS of the RRMS and SPMS subtypes, without the presence of flare-ups during the past three months and aged between 25 and 60 years;
  • an Expanded Disability Status Scale (EDSS) score of ≤7,
  • not presenting depressive symptoms (measured using the Beck Depression Inventory, BDI),
  • not presenting cognitive decline, measured using the Montreal Cognitive Assessment (MoCA) or Minimental Status Examination.
  • In addition, they had to be regularly attending physical therapy and/or occupational therapy rehabilitation treatments.

Treatment and study plan

Mental practice

Other

During each of the 12 treatment sessions, the patient was asked to select two tasks from a list of MP activities, graded by level. Once the task was selected, patients received the specific visual or audio instructions and subsequently performed the task. The recording was viewed three times and the audio instructions were repeated two times. To listen to the audio instructions, the participants were requested to close their eyes in order to aid concentration. After listening to the recordings, the patient was asked to perform the task once again, practicing what had been learnt. After the process was completed, the participant completed a questionnaire and scored each task.

Mental practice + skill training

Other

In this option, six sessions of MP were alternated with six sessions of skills training (ST). The MP protocol was the same as in group A: selecting, performing, visualizing, listening to and scoring the selected tasks. The activities performed in the skills training were based on the Kamm et al. (2015) protocol and bimanual tasks. After the performance of each task, the patients were allowed to rest for 1 or 2 minutes to avoid the appearance of fatigue.

Control Group

Other

The control group only received their usual physical therapy and occupational therapy treatments provided by their association. The treatment mainly consisted of the application of the Bobath concept and the Vojta method, dry needling, myofascial induction therapy, passive mobilizations, training of gross and fine motor coordination of the upper limbs, resistance training and static and dynamic balance training.

Primary outcomes

  1. Nine Hole Peg Test (NHPT). Pre-treatment

    Time frame: Pre-treatment assessments were performed with each patient.

    The higher scores mean a worse outcome.

  2. Box and Block Test (BBT). Pre-treatment

    Time frame: Pre-treatment assessments were performed with each patient.

    The higher scores mean a better outcome.

  3. The ABILHAND questionnaire. Pre-treatment

    Time frame: Pre-treatment assessments were performed with each patient.

    The higher scores mean a better outcome.

  4. The Canadian Occupational Performance Measure (COPM). Pre-treatment

    Time frame: Pre-treatment assessments were performed with each patient.

    The higher scores mean a better outcome.

Secondary outcomes

  1. Nine Hole Peg Test (NHPT). Post-treatment

    Time frame: Immediately after treatment assessments were performed with each patient.

    The higher scores mean a worse outcome.

  2. Box and Block Test (BBT). Post-treatment

    Time frame: Immediately after treatment assessments were performed with each patient.

    The higher scores mean a better outcome.

  3. The ABILHAND questionnaire. Post-treatment

    Time frame: Immediately after treatment assessments were performed with each patient.

    The higher scores mean a better outcome.

  4. The Canadian Occupational Performance Measure (COPM). Post-treatment

    Time frame: Immediately after treatment assessments were performed with each patient.

    The higher scores mean a better outcome.

Other outcomes

  1. Nine Hole Peg Test (NHPT). Three-month follow-up

    Time frame: Three-month follow-up assessments were performed with each patient.

    The higher scores mean a worse outcome.

  2. Box and Block Test (BBT). Three-month follow-up

    Time frame: Three-month follow-up assessments were performed with each patient.

    The higher scores mean a better outcome.

  3. The ABILHAND questionnaire. Three-month follow-up

    Time frame: Three-month follow-up assessments were performed with each patient.

    The higher scores mean a better outcome.

  4. The Canadian Occupational Performance Measure (COPM). Three-month follow-up

    Time frame: Three-month follow-up assessments were performed with each patient.

    The higher scores mean a better outcome.

Sponsors and collaborators

Lead sponsor

Cristina García-Bravo

Other

Registry information

Official study title

Mental Practice and Manipulative Skills Training in Multiple Sclerosis: a Pilot Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 27, 2020
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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