Back to resultsEffectiveness of an Intervention Program for Fine Motor Skills
Primary Purpose
Hand Injuries
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intervention for fine motor skills
Support to activities of daily living
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injuries focused on measuring Frail Elderly, Motor Skills, Upper Extremity
Eligibility Criteria
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.
Sites / Locations
- Maria Encarnación Aguilar Ferrandiz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention for fine motor skills
Support to activities of daily living
Arm Description
Implementation of an well known activity to improve the function of upper extremities
Performing of general activities planned in the centres where the participants are included
Outcomes
Primary Outcome Measures
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
Secondary Outcome Measures
Change from Baseline in General self-efficacy at 8 weeks
Change from Baseline in General self-efficacy at 16 weeks
Change from Baseline in Purdue Pegboard Tests at 8 weeks
Change from Baseline in Purdue Pegboard Tests at 16 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 .
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 .
Change from Baseline in Pinch Gauge at 8 weeks
Change from Baseline in Pinch Gauge at 16 weeks
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02331004
Brief Title
Effectiveness of an Intervention Program for Fine Motor Skills
Official Title
Effectiveness of an Intervention Program for Fine Motor Skills in Institutionalized Elderly Residents: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries
Keywords
Frail Elderly, Motor Skills, Upper Extremity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention for fine motor skills
Arm Type
Active Comparator
Arm Description
Implementation of an well known activity to improve the function of upper extremities
Arm Title
Support to activities of daily living
Arm Type
Placebo Comparator
Arm Description
Performing of general activities planned in the centres where the participants are included
Intervention Type
Other
Intervention Name(s)
Intervention for fine motor skills
Other Intervention Name(s)
Performing of a specific manual activity
Intervention Description
Implementation of an well known activity to improve the function of upper extremities
Intervention Type
Other
Intervention Name(s)
Support to activities of daily living
Other Intervention Name(s)
Performing of activities of daily living
Intervention Description
Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution
Primary Outcome Measure Information:
Title
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks
Time Frame
Sixteen weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in General self-efficacy at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in General self-efficacy at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in Purdue Pegboard Tests at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Purdue Pegboard Tests at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in finger goniometer at 8 weeks
Description
Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .
Time Frame
Eight weeks
Title
Change from Baseline in finger goniometer at 16 weeks
Description
Active and passive measures of motion in first, second and fifth fingers of dominant hand will be recorded .
Time Frame
Sixteen weeks
Title
Change from Baseline in Pinch Gauge at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Pinch Gauge at 16 weeks
Time Frame
Sixteen weeks
Title
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks
Time Frame
Eight weeks
Title
Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks
Time Frame
Sixteen weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Encarnacion ME Aguilar, PdH
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Encarnación Aguilar Ferrandiz
City
Granada
ZIP/Postal Code
18016
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of an Intervention Program for Fine Motor Skills
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