Mental Practice and Manipulative Skills Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325074
• Other study ID #: 220720153515
• Status: Completed
• Phase: N/A
• Start date: September 15, 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2020
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cristina García-Bravo

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Other	The ABILHAND questionnaire. Three-month follow-up	The higher scores mean a better outcome.	Three-month follow-up assessments were performed with each patient.
Other	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.
Primary	Nine Hole Peg Test (NHPT). Pre-treatment	The higher scores mean a worse outcome.	Pre-treatment assessments were performed with each patient.
Primary	Box and Block Test (BBT). Pre-treatment	The higher scores mean a better outcome.	Pre-treatment assessments were performed with each patient.
Primary	The ABILHAND questionnaire. Pre-treatment	The higher scores mean a better outcome.	Pre-treatment assessments were performed with each patient.
Primary	The Canadian Occupational Performance Measure (COPM). Pre-treatment	The higher scores mean a better outcome.	Pre-treatment assessments were performed with each patient.
Secondary	Nine Hole Peg Test (NHPT). Post-treatment	The higher scores mean a worse outcome.	Immediately after treatment assessments were performed with each patient.
Secondary	Box and Block Test (BBT). Post-treatment	The higher scores mean a better outcome.	Immediately after treatment assessments were performed with each patient.
Secondary	The ABILHAND questionnaire. Post-treatment	The higher scores mean a better outcome.	Immediately after treatment assessments were performed with each patient.
Secondary	The Canadian Occupational Performance Measure (COPM). Post-treatment	The higher scores mean a better outcome.	Immediately after treatment assessments were performed with each patient.