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

About this trial
This is an interventional treatment trial for Multiple Sclerosis
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.
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
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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