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Completed

NCT Number: NCT02875054

Camp High 5: Evaluation of the Effect on Upper Limb Function

Randomized control trial to evaluate uni-manual and bimanual upper limb function as well as compare outcomes of varied cast wear in children with hemiplegic cerebral palsy (CP) following a hybrid camp model of modified constraint induced movement therapy (mCIMT) and hand-arm bimanual intensive training (HABIT).

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Key information

Conditions

Neurological Injury Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will range from 2 years to 11 years 11 months of age at time of enrollment. Children under 5 years of age will attend a morning session and children 6 years and older will attend an -Diagnosis: hemiplegia resulting from a neurological Injury
  • Manual Ability Classification System or Mini Manual Ability Classification System classification I-III

Exclusion criteria

  • Botox injection within past 6 months or planned for within 6 months post camp
  • Inability to follow commands
  • Family unable to commit to daily sessions for 4 weeks
  • Unable to tolerate assigned casting protocol (3-24 hours) daily for 4 weeks

Treatment and study plan

Constraint induced movement therapy (CIMT)

Behavioral

Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity

Hand-arm bimanual intensive training (HABIT)

Behavioral

Facilitates the translation of gains to improve goal-directed bimanual performance.

Primary outcomes

  1. Pediatric Motor Activity Log

    Time frame: 6 Months

    parent questionnaire to determine how well and how often the family perceives the child Spontaneously uses their affected Upper Extremity throughout the day at home. This assessment is scored by adding up the parental score and getting an average score.

  2. Assisting Hand Assessment

    Time frame: 6 Months

    Test of hand function in children with difficulties using one of their hands. The AHA measures how effectively the affected hand and arm is used in bimanual performance.

  3. Melbourne-2

    Time frame: 6 Months

    Test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Camp High 5 2016: Evaluation of the Effect on Upper Limb Function

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 23, 2016
Registry last updated
Apr 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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