Effectiveness of an Intervention Program for Fine Motor Skills
May 28, 2015 updated by: Encarnación Aguilar Ferrandiz, Universidad de Granada
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Granada, Spain, 18016
- Maria Encarnación Aguilar Ferrandiz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Institutionalized elderly people, on a full or part-time.
- Voluntary participation.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intervention for fine motor skills
Implementation of an well known activity to improve the function of upper extremities
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Implementation of an well known activity to improve the function of upper extremities
Other Names:
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Placebo Comparator: Support to activities of daily living
Performing of general activities planned in the centres where the participants are included
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Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
|
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
Time Frame: Sixteen weeks
|
Sixteen weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in General self-efficacy at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
|
|
Change from Baseline in General self-efficacy at 16 weeks
Time Frame: Sixteen weeks
|
Sixteen weeks
|
|
|
Change from Baseline in Purdue Pegboard Tests at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
|
|
Change from Baseline in Purdue Pegboard Tests at 16 weeks
Time Frame: Sixteen weeks
|
Sixteen weeks
|
|
|
Change from Baseline in finger goniometer at 8 weeks
Time Frame: Eight weeks
|
Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .
|
Eight weeks
|
|
Change from Baseline in finger goniometer at 16 weeks
Time Frame: Sixteen weeks
|
Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .
|
Sixteen weeks
|
|
Change from Baseline in Pinch Gauge at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
|
|
Change from Baseline in Pinch Gauge at 16 weeks
Time Frame: Sixteen weeks
|
Sixteen weeks
|
|
|
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks
Time Frame: Eight weeks
|
Eight weeks
|
|
|
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks
Time Frame: Sixteen weeks
|
Sixteen weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mª Encarnacion ME Aguilar, PdH, Universidad de Granada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
December 31, 2014
First Submitted That Met QC Criteria
December 31, 2014
First Posted (Estimate)
January 5, 2015
Study Record Updates
Last Update Posted (Estimate)
May 29, 2015
Last Update Submitted That Met QC Criteria
May 28, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fine motor skills
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.