Hand InjuriesNCT02331004
Effectiveness of an Intervention Program for Fine Motor Skills
A study testing Intervention for fine motor skills and Support to activities of daily living in people with Hand Injuries, run by Universidad de Granada at 1 site in Spain.
Trial summary
Investigators have created a protocol of intervention to treating the general disability of upper limbs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hand Injuries
- What is being tested?
- Intervention for fine motor skills and Support to activities of daily living
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- May 2014to Jan 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Institutionalized elderly people, on a full or part-time.
- Voluntary participation.
Who cannot join
- Cognitive impairment (< 23 in normal school population and < 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
- Postural control problems.
- Balance disorders, while the subject is seated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Intervention Program for Fine Motor Skills in Institutionalized Elderly Residents: a Randomized Clinical Trial
Investigators have created a protocol of intervention to treating the general disability of upper limbs.
Read the detailed description
A protocol of intervention for fine motor skills will be performed on institutionalized elderly people.
This protocol consist on implementation of a manual activity that it is well known in the clinical setting.
This activity will enhance several skills such as strength, coordination of upper limbs, range of motion, general auto-efficacy and the quality of life.
The intervention or rehabilitation will be implemented for two month.
- Conditions
- Hand Injuries
- Being tested
- Intervention for fine motor skills, Support to activities of daily living
- Keywords
- Frail Elderly, Motor Skills, Upper Extremity
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention for fine motor skillsOther
Also called Performing of a specific manual activity
Implementation of an well known activity to improve the function of upper extremities
Support to activities of daily livingOther
Also called Performing of activities of daily living
Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution
| Study group | Role | What they receive |
|---|---|---|
| Intervention for fine motor skills | Active comparator | Implementation of an well known activity to improve the function of upper extremities Receives: Other: Intervention for fine motor skills |
| Support to activities of daily living | Placebo comparator | Performing of general activities planned in the centres where the participants are included Receives: Other: Support to activities of daily living |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
Measured: Eight weeks
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
Measured: Sixteen weeks
Secondary outcomes (10)
Change from Baseline in General self-efficacy at 8 weeks
Measured: Eight weeks
Change from Baseline in General self-efficacy at 16 weeks
Measured: Sixteen weeks
Change from Baseline in Purdue Pegboard Tests at 8 weeks
Measured: Eight weeks
Change from Baseline in Purdue Pegboard Tests at 16 weeks
Measured: Sixteen weeks
Change from Baseline in finger goniometer at 8 weeks
Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .
Measured: Eight weeks
Change from Baseline in finger goniometer at 16 weeks
Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .
Measured: Sixteen weeks
Change from Baseline in Pinch Gauge at 8 weeks
Measured: Eight weeks
Change from Baseline in Pinch Gauge at 16 weeks
Measured: Sixteen weeks
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks
Measured: Eight weeks
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks
Measured: Sixteen weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies 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
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Encarnación Aguilar Ferrandiz, Universidad de Granada
- Investigators
- Mª Encarnacion ME Aguilar, PdH, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331004
- Sponsor's protocol ID
- Fine motor skills
- Status last verified
- May 2015
- First submitted
- 31 Dec 2014
- Last updated
- 29 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Intervention Program for Fine Motor Skills in Institutionalized Elderly Residents: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02331004
- Acronym / sponsor ID
- Fine motor skills
- Conditions
- Hand Injuries
- Keywords
- Frail Elderly, Motor Skills, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 5 Jan 2015 (estimated)
- 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.
Investigators have created a protocol of intervention to treating the general disability of upper limbs.
Detailed description
A protocol of intervention for fine motor skills will be performed on institutionalized elderly people.
This protocol consist on implementation of a manual activity that it is well known in the clinical setting.
This activity will enhance several skills such as strength, coordination of upper limbs, range of motion, general auto-efficacy and the quality of life.
The intervention or rehabilitation will be implemented for two month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention for fine motor skills | Active comparator | Other: Intervention for fine motor skillsImplementation of an well known activity to improve the function of upper extremities |
| Support to activities of daily living | Placebo comparator | Other: Support to activities of daily livingPerforming of general activities planned in the centres where the participants are included |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Institutionalized elderly people, on a full or part-time.
- Voluntary participation.
Key exclusion criteria (3 listed)
- Cognitive impairment (< 23 in normal school population and < 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)).
- Postural control problems.
- Balance disorders, while the subject is seated.
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 |
|---|---|---|
| Intervention for fine motor skillsAlso: Performing of a specific manual activityImplementation of an well known activity to improve the function of upper extremities | Other | Intervention for fine motor skills |
| Support to activities of daily livingAlso: Performing of activities of daily livingParticipants are supported and orientated when they are performing some activity of daily living scheduled by the institution | Other | Support to activities of daily living |
Primary outcome
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
Time frame: Eight weeks
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
Time frame: Sixteen weeks
10 secondary outcomes
Change from Baseline in General self-efficacy at 8 weeks
Time frame: Eight weeks
Change from Baseline in General self-efficacy at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in Purdue Pegboard Tests at 8 weeks
Time frame: Eight weeks
Change from Baseline in Purdue Pegboard Tests at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in finger goniometer at 8 weeks
Time frame: Eight weeks
Change from Baseline in finger goniometer at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in Pinch Gauge at 8 weeks
Time frame: Eight weeks
Change from Baseline in Pinch Gauge at 16 weeks
Time frame: Sixteen weeks
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks
Time frame: Eight weeks
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks
Time frame: Sixteen weeks
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 29 May 2015.
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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.
Mª Encarnacion ME Aguilar, PdH principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention for fine motor skills and Support to activities of daily living in people with Hand Injuries, run by Universidad de Granada 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 3 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 29 May 2015. 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?
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?
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks (time frame: Eight weeks). 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 29 May 2015; AzTrials last refreshed its copy on 1 Nov 2026.