Multiple SclerosisNCT04325074
Mental Practice and Manipulative Skills Training in Multiple Sclerosis
A study testing Mental practice and Mental practice + skill training in people with Multiple Sclerosis, run by Cristina García-Bravo.
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. Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Mental practice and Mental practice + skill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: 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.
Read more
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
- Being tested
- Mental practice, Mental practice + skill training, Control group
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental practiceOther
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 trainingOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine Hole Peg Test (NHPT). Pre-treatment
The higher scores mean a worse outcome.
Measured: Pre-treatment assessments were performed with each patient.
Box and Block Test (BBT). Pre-treatment
The higher scores mean a better outcome.
Measured: Pre-treatment assessments were performed with each patient.
The ABILHAND questionnaire. Pre-treatment
The higher scores mean a better outcome.
Measured: Pre-treatment assessments were performed with each patient.
The Canadian Occupational Performance Measure (COPM). Pre-treatment
The higher scores mean a better outcome.
Measured: Pre-treatment assessments were performed with each patient.
Secondary outcomes (4)
Nine Hole Peg Test (NHPT). Post-treatment
The higher scores mean a worse outcome.
Measured: Immediately after treatment assessments were performed with each patient.
Box and Block Test (BBT). Post-treatment
The higher scores mean a better outcome.
Measured: Immediately after treatment assessments were performed with each patient.
The ABILHAND questionnaire. Post-treatment
The higher scores mean a better outcome.
Measured: Immediately after treatment assessments were performed with each patient.
The Canadian Occupational Performance Measure (COPM). Post-treatment
The higher scores mean a better outcome.
Measured: Immediately after treatment assessments were performed with each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start15 Sep 2015
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristina García-Bravo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cristina García-Bravo, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325074
- Sponsor's protocol ID
- 220720153515
- Status last verified
- Mar 2020
- First submitted
- 18 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be sent by email.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental Practice and Manipulative Skills Training in Multiple Sclerosis: a Pilot Study
- ClinicalTrials.gov ID
- NCT04325074
- Acronym / sponsor ID
- 220720153515
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cristina García-BravoUniversity, hospital or other
- Study start
- 15 Sep 2015 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mental practice | Experimental | Other: Mental practiceThe 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. |
| Mental practice + skill training | Experimental | Other: Mental practice + skill trainingThe 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. |
| Control group | Active comparator | Other: Control groupThe final sample therefore comprised of 35 participants (n=35), who were divided into three treatment groups. The sample of control group was n=10. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental practiceDuring 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. | Other | Mental practice |
| Mental practice + skill trainingIn 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. | Other | Mental practice + skill training |
| Control groupThe 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. | Other | Control group |
Primary outcome
Nine Hole Peg Test (NHPT). Pre-treatment
Time frame: Pre-treatment assessments were performed with each patient.
The higher scores mean a worse outcome.
Box and Block Test (BBT). Pre-treatment
Time frame: Pre-treatment assessments were performed with each patient.
The higher scores mean a better outcome.
The ABILHAND questionnaire. Pre-treatment
Time frame: Pre-treatment assessments were performed with each patient.
The higher scores mean a better outcome.
The Canadian Occupational Performance Measure (COPM). Pre-treatment
Time frame: Pre-treatment assessments were performed with each patient.
The higher scores mean a better outcome.
4 secondary outcomes
Nine Hole Peg Test (NHPT). Post-treatment
Time frame: Immediately after treatment assessments were performed with each patient.
Box and Block Test (BBT). Post-treatment
Time frame: Immediately after treatment assessments were performed with each patient.
The ABILHAND questionnaire. Post-treatment
Time frame: Immediately after treatment assessments were performed with each patient.
The Canadian Occupational Performance Measure (COPM). Post-treatment
Time frame: Immediately after treatment assessments were performed with each patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: Yes. The IPD will be sent by email.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mental practice and Mental practice + skill training in people with Multiple Sclerosis, run by Cristina García-Bravo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine Hole Peg Test (NHPT). Pre-treatment (time frame: Pre-treatment assessments were performed with each patient.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020; AzTrials last refreshed its copy on 2 Nov 2026.