Mental Practice and Manipulative Skills Training in Multiple Sclerosis

NCT04325074 | Completed

• 1 other identifier: 220720153515
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

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

  Immediately after treatment assessments were performed with each patient.

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

  Immediately after treatment assessments were performed with each patient.

• The ABILHAND questionnaire. Post-treatment

  Immediately after treatment assessments were performed with each patient.

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

  Immediately after treatment assessments were performed with each patient.

Other Outcomes (4)

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

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

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

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

• The ABILHAND questionnaire. Three-month follow-up

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

Study Arms (3)

Mental practice

EXPERIMENTAL

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

Mental practice + skill training

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

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

Interventions

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

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.

Mental practice + skill training

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.

Control group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Cristina García-Bravo: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 27, 2020
• Study Start: September 15, 2015
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: At present
• Access Criteria: cristina.bravo@urjc.es