Effectiveness of an Intervention Program for Fine Motor Skills
1 other identifier
interventional
40
1 country
1
Brief Summary
Investigators have created a protocol of intervention to treating the general disability of upper limbs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 5, 2015
CompletedMay 29, 2015
May 1, 2015
8 months
December 31, 2014
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
Eight weeks
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
Sixteen weeks
Secondary Outcomes (10)
Change from Baseline in General self-efficacy at 8 weeks
Eight weeks
Change from Baseline in General self-efficacy at 16 weeks
Sixteen weeks
Change from Baseline in Purdue Pegboard Tests at 8 weeks
Eight weeks
Change from Baseline in Purdue Pegboard Tests at 16 weeks
Sixteen weeks
Change from Baseline in finger goniometer at 8 weeks
Eight weeks
- +5 more secondary outcomes
Study Arms (2)
Intervention for fine motor skills
ACTIVE COMPARATORImplementation of an well known activity to improve the function of upper extremities
Support to activities of daily living
PLACEBO COMPARATORPerforming of general activities planned in the centres where the participants are included
Interventions
Implementation of an well known activity to improve the function of upper extremities
Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution
Eligibility Criteria
You may qualify if:
- Institutionalized elderly people, on a full or part-time.
- Voluntary participation.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maria Encarnación Aguilar Ferrandiz
Granada, Granada, 18016, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mª Encarnacion ME Aguilar, PdH
Universidad de Granada
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Encarnación Aguilar Ferrandiz
Study Record Dates
First Submitted
December 31, 2014
First Posted
January 5, 2015
Study Start
May 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
May 29, 2015
Record last verified: 2015-05