Upper extremity outcome measures in non-ambulant Duchenne muscular dystrophy patients

Upper extremity outcome measures in non-ambulant Duchenne muscular dystrophy patients - Upper limb outcome measures in DMD

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50471

Enrollment

Registered

2018-03-01

Start date

2018-03-23

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DMD patients Duchenne Duchenne muscular dystrophy

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for non-ambulant boys and men with Duchenne muscular dystrophy: 1. Age 8 years or above. 2. Non-ambulant defined as not able to walk five meters indoors unaided. 3. The diagnosis of DMD must be confirmed by genetic testing. , Inclusion criteria for male healthy controls: 1. Healthy age-matched boys and men of 8 years or older. , Inclusion criteria for Leap Motion sub study healthy controls: 1. Healthy men or women aged 18 years or older.

Exclusion criteria

Exclusion criteria: Exclusion criteria for non-ambulant boys and men with Duchenne muscular dystrophy: 1. Exposure to an investigational drug within 6 months prior to the start of the study. 2. Intellectual impairment that would interfere with the possibility to follow instructions. 3. Inability to lie still for 45 minutes. 4. Recent (

Design outcomes

Primary

Measure	Time frame
Primary study endpoints: - Biceps endpoint: Additive predictive value of biceps FF to age on the moment of loss of the ability to bring the hand to the mouth with a 200g weighing cup (supporting elbow on table is allowed), defined by hazard ratio. - Thenar endpoint: Additive predictive value of thenar FF to age on the moment of loss of the ability to play for 10 minutes on a game console, defined by hazard ratio.	—

Measure

Time frame

Primary study endpoints: - Biceps endpoint: Additive predictive value of biceps FF to age on the moment of loss of the ability to bring the hand to the mouth with a 200g weighing cup (supporting elbow on table is allowed), defined by hazard ratio. - Thenar endpoint: Additive predictive value of thenar FF to age on the moment of loss of the ability to play for 10 minutes on a game console, defined by hazard ratio.

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Secondary

Measure	Time frame
-	—

Countries

Netherlands

Outcome results