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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02331004
Other study ID # Fine motor skills
Secondary ID
Status Completed
Phase N/A
First received December 31, 2014
Last updated May 28, 2015
Start date May 2014
Est. completion date January 2015

Study information

Verified date May 2015
Source Universidad de Granada
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

Investigators have created a protocol of intervention to treating the general disability of upper limbs.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Intervention for fine motor skills
Implementation of an well known activity to improve the function of upper extremities
Support to activities of daily living
Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution

Locations

Country Name City State
Spain Maria Encarnación Aguilar Ferrandiz Granada

Sponsors (1)

Lead Sponsor Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 8 weeks Eight weeks No
Primary Change from Baseline in Disability of the Arm, Shoulder and Hand (DASH) questionnaire at 16 weeks Sixteen weeks No
Secondary Change from Baseline in General self-efficacy at 8 weeks Eight weeks No
Secondary Change from Baseline in General self-efficacy at 16 weeks Sixteen weeks No
Secondary Change from Baseline in Purdue Pegboard Tests at 8 weeks Eight weeks No
Secondary Change from Baseline in Purdue Pegboard Tests at 16 weeks Sixteen weeks No
Secondary 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 . Eight weeks No
Secondary 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 . Sixteen weeks No
Secondary Change from Baseline in Pinch Gauge at 8 weeks Eight weeks No
Secondary Change from Baseline in Pinch Gauge at 16 weeks Sixteen weeks No
Secondary Change from Baseline in Short-Form health survey questionnaire (SF-36) at 8 weeks Eight weeks No
Secondary Change from Baseline in Short-Form health survey questionnaire (SF-36) at 16 weeks Sixteen weeks No
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