Duchenne Muscular Dystrophy Clinical Trial
Official title:
Investigation Of Factors Affecting Hand Functions in Nonambulatory Patients With Duchenne Muscular Dystrophy
NCT number | NCT03521271 |
Other study ID # | GO 17/307 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 5, 2017 |
Est. completion date | January 26, 2018 |
Verified date | May 2018 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study, determining the factors affecting the hand functions of children with Duchenne Muscular Dystrophy who have lost their independent ambulatory ability and determining the effects on the overall upper extremity performance and quality of life of the determined factors.
Status | Completed |
Enrollment | 23 |
Est. completion date | January 26, 2018 |
Est. primary completion date | January 26, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 8 Years to 16 Years |
Eligibility |
Inclusion Criteria: - Having a Duchenne Muscular Dystrophy diagnosis by a practicing physician, - Between the ages of 8-16 years, - Having lost ambulation ability, - Brooke Upper Extremity Functional Classification (1-5) - To have motivation and co-operation with physiotherapist for evaluations to be made Exclusion Criteria: - To maintain the capacity of independent ambulance, - Having cooperative disorder or serious mental disorder, - Any spinal and / or upper extremity injuries and / or surgery in the last 6 months, - Having any systemic disease other than DMD, - Not volunteering to participate in the study |
Country | Name | City | State |
---|---|---|---|
Turkey | Hacettepe University | Ankara | Samanpazari/Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brooke Upper Extremity Functional Classification (1-6) | Children's functional levels were assessed with Brooke Upper Extremity Functional Classification (BUEFS) and children with a BUEFS score between 1-5 were included in the study. Starting with arms at sides, can abduct arms in a full circle until they touch above head Can raise arms above head only by flexing elbow or using accesory muscles Cannot raise arms above head but can raise a glass of water to mouth (using both hands if necessary) Can raise hands to mouth but cannot raise a glass of water to mouth Cannot raise hand to mouth but can use hands to hold pen or pick up pennies from table Cannot raise hands to mouth and has no useful function of hands |
2 minutes | |
Primary | Passive joint range of motion | Passive range of motions were assessed with goniometer and recorded limitations. | 10 minutes | |
Primary | Upper extremity muscle strength | Hand held dynamometer | 20 minutes | |
Primary | Thumb opposition | Thumb opposition was assessed by Kapandji score (1-10). Score Location achieved Radial side of the proximal phalanx of the 2nd phalanx Radial side of the middle phalanx of the 2nd phalanx Tip of the 2nd phalanx Tip of the 3th phalanx Tip of the 4th phalanx Tip of the 5th phalanx Distal interphalangeal joint crease of the 5th phalanx Proximal interphalangeal joint crease of the 5th phalanx Metacarpophalangeal joint crease of the 5th phalanx Distal palmar crease |
2 minutes | |
Primary | Lateral, tripod, two-point pinch strength | Pinchmeter | 3 minutes | |
Primary | Performance of the upper extremity | Performance of the Upper Limb (PUL) (0-74) is including three dimension: Shoulder dimension (0-16) Elbow dimension (0-34) Distal dimension (0-24) |
15 minutes | |
Primary | Hand function | ABILHAND-Kids (0-36) | 3 minutes | |
Primary | Activity limitations | ACTIVLIM (0-36) | 3 minutes | |
Primary | Gross grip strength | Hand dynamometer | 2 minutes | |
Secondary | Quality of life assessment of children (0-100) | PedsQL-Child report | 5 minutes | |
Secondary | Quality of life assessment of parents (0-100) | PedsQL-Parent report | 5 minutes |
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