Mental Practice and Manipulative Skills Training in Multiple Sclerosis

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Mental practice; Other: Mental practice + skill training; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Mental practice; 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.	Other: Mental practice; 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.
EXPERIMENTAL: Mental practice + skill training; 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.	Other: Mental practice + skill training; 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.
ACTIVE_COMPARATOR: Control group; 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.	Other: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test (NHPT). Pre-treatment	The higher scores mean a worse outcome.	Pre-treatment assessments were performed with each patient.
Box and Block Test (BBT). Pre-treatment	The higher scores mean a better outcome.	Pre-treatment assessments were performed with each patient.
The ABILHAND questionnaire. Pre-treatment	The higher scores mean a better outcome.	Pre-treatment assessments were performed with each patient.
The Canadian Occupational Performance Measure (COPM). Pre-treatment	The higher scores mean a better outcome.	Pre-treatment assessments were performed with each patient.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test (NHPT). Post-treatment	The higher scores mean a worse outcome.	Immediately after treatment assessments were performed with each patient.
Box and Block Test (BBT). Post-treatment	The higher scores mean a better outcome.	Immediately after treatment assessments were performed with each patient.
The ABILHAND questionnaire. Post-treatment	The higher scores mean a better outcome.	Immediately after treatment assessments were performed with each patient.
The Canadian Occupational Performance Measure (COPM). Post-treatment	The higher scores mean a better outcome.	Immediately after treatment assessments were performed with each patient.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nine Hole Peg Test (NHPT). Three-month follow-up	The higher scores mean a worse outcome.	Three-month follow-up assessments were performed with each patient.
Box and Block Test (BBT). Three-month follow-up	The higher scores mean a better outcome.	Three-month follow-up assessments were performed with each patient.
The ABILHAND questionnaire. Three-month follow-up	The higher scores mean a better outcome.	Three-month follow-up assessments were performed with each patient.
The Canadian Occupational Performance Measure (COPM). Three-month follow-up	The higher scores mean a better outcome.	Three-month follow-up assessments were performed with each patient.

Collaborators and Investigators

• Sponsor: Cristina García-Bravo

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 220720153515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The IPD will be sent by email.
• IPD Sharing Time Frame: At present
• IPD Sharing Access Criteria: cristina.bravo@urjc.es
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No