Hand GraspNCT04545684
Effects of Mental Practice on Manual Gripping Motor Function
A study testing Motor imagery in people with Hand Grasp, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
The main objective is to evaluate and quantify the manual gripping force caused by mental practice Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand Grasp
- What is being tested?
- Motor imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2020to 26 Feb 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 60
- Healthy and with no pain subjects
Who cannot join
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
- Underage subjects
- Subjects with pain at the time of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mental Practice on Manual Gripping Motor Function: A Randomized Controlled Trial
The main objective is to evaluate and quantify the manual gripping force caused by mental practice
- Conditions
- Hand Grasp
- Being tested
- Motor imagery, Placebo intervention
- Keywords
- Motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor imageryBehavioural
The person will have to imagine different scenarios of manual gripping
Placebo interventionBehavioural
The placebo group will imagine a place without the presence of humans.
| Study group | Role | What they receive |
|---|---|---|
| Mental practice | Experimental | Not described Receives: Behavioral: Motor imagery |
| Placebo group | Placebo comparator | Not described Receives: Behavioral: Placebo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
It is a variable of gripping force measured in the unit of Newtons
Measured: Change from baseline and immediately post-intervention
Pain pressure threshold
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high
Measured: Change from baseline and immediately post-intervention
Secondary outcomes (2)
Visual and Kinesthetic Motor Imagery Ability
Visual and Kinesthetic Motor Imagery Ability will be measured with Movement Imagery Questionnaire-Revised (MIQ-R). MIQ-R has four movements repeated in two subscales, a visual and a kinesthetic one. Additionally, a score between 1 and 7 is assigned, with 1 representing difficulty in picturing the motor image or difficulty in feeling the movement previously made, and 7 representing the maximum ease. The internal consistencies of the MIQ-R have been consistently adequate with Cronbach's α coefficients ranging above 0.84 for the total scale, 0.80 for de visual subscale and 0.84 for the kinesthetic subscale.
Measured: Immediately before the intervention
The degree of physical activity
The degree of physical activity was objectified through the The International Physical Activity Questionnaire (IPAQ) questionnaire, which allows the subjects to be divided into three groups according to their level of activity, which can be high, moderate, and low or inactive. The IPAQ consists of 7 questions about the frequency, duration and intensity of activity (moderate and intense) performed in the last seven days, as well as walking and sitting time on a workday. The IPAQ scoring protocol assigns the following MET values to walking, moderate, and vigorous intensity activity: 3.3 METs, 4.0 METs, and 8.0 METs, respectively.
Measured: Immediately before the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start30 Nov 2020 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion26 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand GraspStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Universitario La Salle
- Responsible party
- Principal investigator, Roy La Touche Arbizu, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545684
- Sponsor's protocol ID
- uammadrid31
- Status last verified
- Sep 2020
- First submitted
- 4 Sep 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mental Practice on Manual Gripping Motor Function: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04545684
- Acronym / sponsor ID
- uammadrid31
- Conditions
- Hand Grasp
- Keywords
- Motor imagery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Universitario La Salle
- Study start
- 30 Nov 2020 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 26 Feb 2021 (estimated)
- First posted
- 11 Sep 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.
The main objective is to evaluate and quantify the manual gripping force caused by mental practice
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mental practice | Experimental | Behavioral: Motor imagery |
| Placebo group | Placebo comparator | Behavioral: Placebo intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 60
- Healthy and with no pain subjects
Key exclusion criteria (7 listed)
- Any cognitive impairment that hindered viewing of audiovisual material.
- Difficulty understanding or communicating.
- Presence of systemic pathology, Central Nervous System or rheumatic disease.
- Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
- Collaboration of pregnant women.
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 |
|---|---|---|
| Motor imageryThe person will have to imagine different scenarios of manual gripping | Behavioural | Mental practice |
| Placebo interventionThe placebo group will imagine a place without the presence of humans. | Behavioural | Placebo group |
Primary outcome
Hand grip strength
Time frame: Change from baseline and immediately post-intervention
It is a variable of gripping force measured in the unit of Newtons
Pain pressure threshold
Time frame: Change from baseline and immediately post-intervention
Pressure Pain Threshold (PPT) is one of these tests and it is defined as the minimum force applied which induces pain. The measurement shall be carried out by using an algometer (pressure device that induces mechanical stimuli) is to standardize the amount of pressure applied in the neck region. The reliability of pressure pain thresholds according to raters or measurement frequencies is relatively high
2 secondary outcomes
Visual and Kinesthetic Motor Imagery Ability
Time frame: Immediately before the intervention
The degree of physical activity
Time frame: Immediately before the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor imagery in people with Hand Grasp, run by Universidad Autonoma de Madrid at 1 site in Spain.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Roy A La Tocuhe, physiotherapist PhD (917401980 ext. 313, roylatouche@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand grip strength (time frame: Change from baseline and immediately post-intervention). The study lists 2 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 4 Nov 2020.