AOT and ICT for Hemiplegia

NCT03094455 | Completed DMC

• 1 other identifier: GR-2011-02350053 AOT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is chosen as primary outcome measure and a sample size of 10 per group is required. The rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.

Conditions

Hemiplegia; Hemiplegic Cerebral Palsy

Keywords

Tele-rehabilitation; Action Observation; Mirror neurons; ICT

Outcome Measures

Primary Outcomes (1)

• Changes in the Assisting Hand Assessment

  This assessment measures upper limb function during bimanual activities. The test evaluates spontaneous use of assisting hand during a semi-structured session with specific toys or tasks with objects requiring bimanual handling

  Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2)

Secondary Outcomes (3)

• Changes in Box and Block Test

  Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2)

• Changes in Melbourne Assessment of Unilateral Upper Limb Function

  Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2)

• Changes in ABILHAND-kids

  Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2)

Other Outcomes (5)

• Participation and Environment Measure - Children and Youth (PEM-CY)

  Baseline (T0) and T3 (16 weeks after T2)

• Cerebral Palsy Quality of Life Questionnaire

  Baseline (T0) and T3 (16 weeks after T2)

• Quantitative measurement of reaching and grasping capabilities by means of a sensorized object that allow different grasping tasks

  Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2)

Study Arms (2)

Experimental group

EXPERIMENTAL

AOT is based on the observation of meaningful actions followed by their execution

Other: Experimental group

Control group

OTHER

Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group

Other: Experimental group

Interventions

Experimental group OTHER

Observation of video sequences showing uni¬manual or bimanual goal-directed actions followed by the execution of the observed actions either with plegic upper limb for unimanual or with both upper limbs for bimanual actions.

Also known as: AOT

Control group; Experimental group

Eligibility Criteria

• Age: 5 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• confirmed diagnosis of spastic UCP
• age between 15 and 20 years
• predominant spasticity at upper limb upper limb
• minimal ability to grasp and hold objects, also passively, with affected hand (House functional classification score 2 or more)
• sufficient cooperation, cognitive and communicative understanding to perform assessments and participate in the intervention
• subjects and parents able to commit to the intensive therapy program for a period of 3 weeks

You may not qualify if:

• Children who had sustained previous orthopedic surgery or botulinum toxin A injection in the UL within 6 months prior to study entry were excluded.

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• BioRobotics Institute: collaborator

Study Sites (1)

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

Location

Related Publications (4)

• Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Biagi L, Tosetti M, Fogassi L, Cioni G. Upper limb children action-observation training (UP-CAT): a randomised controlled trial in hemiplegic cerebral palsy. BMC Neurol. 2011 Jun 28;11:80. doi: 10.1186/1471-2377-11-80.

  PMID: 21711525 BACKGROUND

• Sgandurra G, Ferrari A, Cossu G, Guzzetta A, Fogassi L, Cioni G. Randomized trial of observation and execution of upper extremity actions versus action alone in children with unilateral cerebral palsy. Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):808-15. doi: 10.1177/1545968313497101. Epub 2013 Jul 25.

  PMID: 23886886 BACKGROUND

• Beani E, Menici V, Ferrari A, Cioni G, Sgandurra G. Feasibility of a Home-Based Action Observation Training for Children With Unilateral Cerebral Palsy: An Explorative Study. Front Neurol. 2020 Feb 28;11:16. doi: 10.3389/fneur.2020.00016. eCollection 2020.

  PMID: 32180754 DERIVED

• Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.

  PMID: 29764869 DERIVED

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It will be a parallel RCT with a waitlist design

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: March 29, 2017
• Study Start: March 29, 2017
• Primary Completion: October 29, 2018
• Study Completion: November 29, 2018
• Last Updated: August 7, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)