Constraint-Induced Movement Therapy and Action Observation Training in Children With Unilateral Cerebral Palsy

NCT03256357 | Completed

• 1 other identifier: CIMT and AOT in unilateral CP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, controlled, and evaluator-blinded trail will be carried out comparing CIMT with or without AOT on sensorimotor outcome in children with unilateral CP aged 5 to 12 years. Additionally the potential role of neurological factors, including the anatomical characterization of the brain lesion, structural/functional connectivity and cortical reorganization, on treatment response will be investigated.

Conditions

Cerebral Palsy

Keywords

unilateral cerebral palsy; upper limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Assisting Hand Assessment (AHA)

  The AHA, a Rasch-based performance scale, measures how effectively the affected hand is spontaneously used during performance of bimanual tasks.

  baseline, pre and post intervention (within one week), 6 months follow-up

Secondary Outcomes (13)

• Change in Melbourne Assessment of Unilateral Upper Limb Function

  baseline, pre and post intervention (within one week), 6 months follow-up

• Change in Jebsen-Taylor Hand Function Test

  baseline, pre and post intervention (within one week), 6 months follow-up

• Change in Tyneside Pegboard test

  pre and post intervention (within one week), 6 months follow-up

• Change in passive range of motion (PROM)

  baseline, pre and post intervention (within one week), 6 months follow-up

• Change in muscle tone

  baseline, pre and post intervention (within one week), 6 months follow-up

Other Outcomes (4)

• Structural Magnetic Resonance Imaging (MRI)

  baseline

• Resting state functional Magnetic Resonance Imaging (rsfMRI)

  baseline

• Diffusion weighted imaging

  baseline

Study Arms (2)

CIMT + AOT

ACTIVE COMPARATOR

In a 2-week day camp model children receive constraint-induced movement therapy for six hours a day, for 9 out of 11 consecutive days. All children wear a tailor made hand splint on the unaffected upper limb for 6 hours per day while performing unimanual exercises individually or in a group based on shaping and repetitive practice. Action observation training consists of 15 sessions of 1 hour. Children watch video sequences showing goal-directed actions and subsequently execute the observed actions with the affected upper limb.

Behavioral: Constraint-induced movement therapy; Behavioral: Action observation training

CIMT + POT

PLACEBO COMPARATOR

In a 2-week day camp model children receive constraint- induced movement therapy for six hours a day, for 9 out of 11 consecutive days. All children wear a tailor made hand splint on the unaffected upper limb for 6 hours per day while performing unimanual exercises individually or in a group based on shaping and repetitive practice. Placebo observation training consists of 15 sessions of 1 hour.This group performs the same actions after watching computer games without biological movements.

Behavioral: Constraint-induced movement therapy; Behavioral: Placebo observation training

Interventions

Constraint-induced movement therapy BEHAVIORAL

In a 2-week day camp model children receive constraint- induced movement therapy for six hours a day, for 9 out of 11 consecutive days. All children wear a tailor made hand splint on the unaffected upper limb for 6 hours per day while performing unimanual exercises individually or in a group based on shaping and repetitive practice.

CIMT + AOT; CIMT + POT

Action observation training BEHAVIORAL

Action observation training consists of 15 sessions of 1 hour. Children watch 3 minute video clips of unimanual goal-directed actions followed by 3 minutes of execution of the actions.

CIMT + AOT

Placebo observation training BEHAVIORAL

Placebo observation training consists of 15 sessions of 1 hour. Children perform the same actions as the AOT training after watching computer games without biological movements.

CIMT + POT

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• confirmed diagnosis of unilateral CP
• aged 5-12 years
• sufficient cooperation to comprehend and complete the test procedure
• minimal ability to actively grasp and stabilize an object

You may not qualify if:

• upper limb surgery two years prior to enrollment
• botulinum toxin A injections six months prior to enrollment

Sponsors & Collaborators

• KU Leuven: lead
• ETH Zurich (Switzerland): collaborator
• University of Pisa: collaborator

Study Sites (1)

KU Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

• Simon-Martinez C, Mailleux L, Hoskens J, Ortibus E, Jaspers E, Wenderoth N, Sgandurra G, Cioni G, Molenaers G, Klingels K, Feys H. Randomized controlled trial combining constraint-induced movement therapy and action-observation training in unilateral cerebral palsy: clinical effects and influencing factors of treatment response. Ther Adv Neurol Disord. 2020 Jan 6;13:1756286419898065. doi: 10.1177/1756286419898065. eCollection 2020.

  PMID: 32031542 DERIVED

• Simon-Martinez C, Mailleux L, Ortibus E, Fehrenbach A, Sgandurra G, Cioni G, Desloovere K, Wenderoth N, Demaerel P, Sunaert S, Molenaers G, Feys H, Klingels K. Combining constraint-induced movement therapy and action-observation training in children with unilateral cerebral palsy: a randomized controlled trial. BMC Pediatr. 2018 Jul 31;18(1):250. doi: 10.1186/s12887-018-1228-2.

  PMID: 30064396 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Cristina Simon-Martinez

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Hilde Feys, Prof

  KU Leuven

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: August 22, 2017
• Study Start: January 1, 2014
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

BE (1)