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

NYU Langone Health logo

NYU Langone Health

Status

Completed

Conditions

Hemiplegia
Neurological Injury

Treatments

Behavioral: Hand-arm bimanual intensive training (HABIT)
Behavioral: Constraint induced movement therapy (CIMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02875054
16-00990

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

Continued Casting
Active Comparator group
Description:
Participants with 24 hour cast wear (continued casting) for the entire duration of the constraint portion of camp (2 initial weeks).
Treatment:
Behavioral: Hand-arm bimanual intensive training (HABIT)
Behavioral: Constraint induced movement therapy (CIMT)
Intermittent Casting
Active Comparator group
Description:
Participants who wear a univalve cast for 3 hours of constraint camp with home exercise program of 2 hours cast wear on the weekends (intermittent casting).
Treatment:
Behavioral: Hand-arm bimanual intensive training (HABIT)
Behavioral: Constraint induced movement therapy (CIMT)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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