CClinicalTrials.gg
Status unknownNCT03530982Updated Feb 15, 2019

Intensive Goal Training for Adolescents With Cerebral Palsy

An interventional study of Intensive goal training in Cerebral Palsy, sponsored by Federal University of Minas Gerais. Status unknown at 1 site in Brazil. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-02-15.

Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
12 Years to 17 Years
Sex
All
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Study summary

Adolescents with cerebral palsy (CP) present important limitations for the performance of daily living activities. The aims of the study is to evaluate the feasibility and effects of an intensive goal training protocol for adolescents with CP. He hypothesize that adolescents submitted to the studied protocol will present improvements in performance and satisfaction of prioritized functional goals.

Read the detailed description

We will conduct a feasibility study to assess the implementation and the possible effects of an intensive individualized goal training with adolescents with CP. Adolescents will select up to 5 functional goals to be trained during a 2 weeks, 3 hour-daily training, totalling 30 hours across 2 weeks. Moreover, they will be asked to daily practice these activities at home along the intervention period.

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Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 433 are open to participants now.

This study's planned enrollment of 20 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Medical diagnosis of bilateral CP;
  • Age between 12 and 17 years old;
  • Manual Ability Classification System (MACS) ranging from levels I to III;
  • Gross Motor Function Classification System (GMFCS) ranging from levels I to IV;
  • Ability to understand verbal instructions.

Exclusion criteria

Exclusion Criteria:

  • Botulinum toxin or surgery in upper limbs in the previous 6 months of the study.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Intervention group

    Intensive goal training of relevant activities reported by adolescents in the beginning of the study. Therapists will grade the level of complexity of the proposed activities, considering the relevant movements, task demands and contextual factors involved in the performance of each task. Adolescents will be asked to practice these activities at home (1 hour/daily) and to discuss their difficulties and improvements with the therapists. The intervention will be provided in a day-camp model.

    Other: Intensive goal training

Interventions

  • OtherIntensive goal training

    Intensive goal training : 30 hours during 2 weeks

    Also known as: intensive individualized functional training

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What researchers measure

Primary outcomes

  1. Change in Functional Goals

    Canadian Occupational Performance Measure (COPM) (ranging 1-10; higher values, better outcomes)

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

  2. Change in Daily functioning- Self-Care

    Pediatric Evaluation Disability Inventory (PEDI) self-care: ranging from 0-63; higher values, better outcomes

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

  3. Change in Daily functioning- Mobility

    Pediatric Evaluation Disability Inventory (PEDI) mobility: ranging from 0-55; higher values, better outcomes

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

Secondary outcomes

  1. Change in Manual dexterity

    Box \& Blocks Test (BBT)- number of blocks that are transported during 1 minute (there is no established max-min, higher values, better outcome)

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

  2. Change in Gross motor function

    Gross Motor Function Measure (GMFM): gross motor function abilities assessed in activities from 5 domains: lying and rolling; seating; crawling and kneeling; standing; walking, running and jumping. higher scores, better outcome

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

  3. Change in Participation at home

    Participation Environment Measure: Children and Youth (PEM-CY): Structured questionnaire to assess the frequency and level of involvement in daily living tasks (home scale will be used) higher scores, better outcomes

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

  4. Change in Participation in household activities

    Children´s Helping Out: Responsibility, Expectations and Supports (CHORES): structured questionnaire to assess the frequency and level of assistance in household activities: higher scores, better outcomes

    Time frame: 1 month before intervention; pre-intervention; immediate post-intervention, 3-month follow-up

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Study locations

1 of 1 sites recruiting
  • Associação Mineira de Reabilitação
    Belo Horizonte, Minas Gerais, Brazil
    • Priscilla B Figueiredo · Contact · 3198839646
    Recruiting
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References and documents

Publications

  • Bleyenheuft Y, Ebner-Karestinos D, Surana B, Paradis J, Sidiropoulos A, Renders A, Friel KM, Brandao M, Rameckers E, Gordon AM. Intensive upper- and lower-extremity training for children with bilateral cerebral palsy: a quasi-randomized trial. Dev Med Child Neurol. 2017 Jun;59(6):625-633. doi: 10.1111/dmcn.13379. Epub 2017 Jan 30. PubMed 28133725 ↗
  • Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039. PubMed 17044964 ↗
  • de Brito Brandao M, Gordon AM, Mancini MC. Functional impact of constraint therapy and bimanual training in children with cerebral palsy: a randomized controlled trial. Am J Occup Ther. 2012 Nov-Dec;66(6):672-81. doi: 10.5014/ajot.2012.004622. PubMed 23106987 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03530982
Lead sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Responsible party
MARINA B BRANDAO (Professor, Federal University of Minas Gerais) — Principal investigator
First posted
May 21, 2018
Start date
Jun 2, 2018
Primary completion
Jun 30, 2019 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Feb 15, 2019

Study contacts

MARINA B BRANDAO, PhD
Contact
marinabbrandao@gmail.com
3188396466
MARINA D BRANDAO, PhD
Contact
marinabbrandao@gmail.com
+553188396466

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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