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Mental Practice and Manipulative Skills Training in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mental practice
Mental practice + skill training
Control group
Sponsored by
Cristina García-Bravo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Mental practice

    Mental practice + skill training

    Control group

    Arm Description

    The final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of mental practice group was n=12.

    The final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of mental practice + skills training group was n=13.

    The final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of control group was n=10.

    Outcomes

    Primary Outcome Measures

    Nine Hole Peg Test (NHPT). Pre-treatment
    The higher scores mean a worse outcome.
    Box and Block Test (BBT). Pre-treatment
    The higher scores mean a better outcome.
    The ABILHAND questionnaire. Pre-treatment
    The higher scores mean a better outcome.
    The Canadian Occupational Performance Measure (COPM). Pre-treatment
    The higher scores mean a better outcome.

    Secondary Outcome Measures

    Nine Hole Peg Test (NHPT). Post-treatment
    The higher scores mean a worse outcome.
    Box and Block Test (BBT). Post-treatment
    The higher scores mean a better outcome.
    The ABILHAND questionnaire. Post-treatment
    The higher scores mean a better outcome.
    The Canadian Occupational Performance Measure (COPM). Post-treatment
    The higher scores mean a better outcome.

    Full Information

    First Posted
    March 18, 2020
    Last Updated
    March 25, 2020
    Sponsor
    Cristina García-Bravo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04325074
    Brief Title
    Mental Practice and Manipulative Skills Training in Multiple Sclerosis
    Official Title
    Mental Practice and Manipulative Skills Training in Multiple Sclerosis: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 15, 2015 (Actual)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Cristina García-Bravo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mental practice
    Arm Type
    Experimental
    Arm Description
    The final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of mental practice group was n=12.
    Arm Title
    Mental practice + skill training
    Arm Type
    Experimental
    Arm Description
    The final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of mental practice + skills training group was n=13.
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    The final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of control group was n=10.
    Intervention Type
    Other
    Intervention Name(s)
    Mental practice
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Mental practice + skill training
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Control group
    Intervention Description
    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 Outcome Measure Information:
    Title
    Nine Hole Peg Test (NHPT). Pre-treatment
    Description
    The higher scores mean a worse outcome.
    Time Frame
    Pre-treatment assessments were performed with each patient.
    Title
    Box and Block Test (BBT). Pre-treatment
    Description
    The higher scores mean a better outcome.
    Time Frame
    Pre-treatment assessments were performed with each patient.
    Title
    The ABILHAND questionnaire. Pre-treatment
    Description
    The higher scores mean a better outcome.
    Time Frame
    Pre-treatment assessments were performed with each patient.
    Title
    The Canadian Occupational Performance Measure (COPM). Pre-treatment
    Description
    The higher scores mean a better outcome.
    Time Frame
    Pre-treatment assessments were performed with each patient.
    Secondary Outcome Measure Information:
    Title
    Nine Hole Peg Test (NHPT). Post-treatment
    Description
    The higher scores mean a worse outcome.
    Time Frame
    Immediately after treatment assessments were performed with each patient.
    Title
    Box and Block Test (BBT). Post-treatment
    Description
    The higher scores mean a better outcome.
    Time Frame
    Immediately after treatment assessments were performed with each patient.
    Title
    The ABILHAND questionnaire. Post-treatment
    Description
    The higher scores mean a better outcome.
    Time Frame
    Immediately after treatment assessments were performed with each patient.
    Title
    The Canadian Occupational Performance Measure (COPM). Post-treatment
    Description
    The higher scores mean a better outcome.
    Time Frame
    Immediately after treatment assessments were performed with each patient.
    Other Pre-specified Outcome Measures:
    Title
    Nine Hole Peg Test (NHPT). Three-month follow-up
    Description
    The higher scores mean a worse outcome.
    Time Frame
    Three-month follow-up assessments were performed with each patient.
    Title
    Box and Block Test (BBT). Three-month follow-up
    Description
    The higher scores mean a better outcome.
    Time Frame
    Three-month follow-up assessments were performed with each patient.
    Title
    The ABILHAND questionnaire. Three-month follow-up
    Description
    The higher scores mean a better outcome.
    Time Frame
    Three-month follow-up assessments were performed with each patient.
    Title
    The Canadian Occupational Performance Measure (COPM). Three-month follow-up
    Description
    The higher scores mean a better outcome.
    Time Frame
    Three-month follow-up assessments were performed with each patient.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The IPD will be sent by email.
    IPD Sharing Time Frame
    At present
    IPD Sharing Access Criteria
    cristina.bravo@urjc.es

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    Mental Practice and Manipulative Skills Training in Multiple Sclerosis

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