AOT and ICT for Hemiplegia (Tele-UPCAT)

Action-Observation Therapy (AOT) and Information and Communications Technologies (ICT) for Home Rehabilitation of Hemiplegia

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: Experimental group

Detailed Description

A waitlist control, evaluator-blinded, randomized trial (RCT) will be conducted according to CONSORT guidelines. Each participant will be randomized to either:

1. Immediate intervention group (Experimental group). Children will receive immediately the system for 3 weeks.
2. Waitlist delayed intervention (Control group). Children will continue standard care for 3 weeks and then will receive the system as the Experimental group.

As such, all participants will receive the AOT training. The system will provide an in-home, individualized, intensive treatment based on the AOT. The system will be delivered at home and the children will perform a 60-minute training session 5 days a week for 3 consecutive weeks. For the Immediate intervention group, follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 3 weeks (T1), and then 8 and 24 weeks after T1(T2 and T3). For the Waitlist group, the assessments will be conducted before T0 and 3 weeks after (T1) the standard care, then they will follow the same timeline of the first group (T1 plus, after the AOT intervention) and 8 and 24 weeks after T1 Puls (T2 and T3). The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each center. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa
    • Calambrone, Pisa, Italy, 56128
      • IRCCS Stella Maris Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; AOT is based on the observation of meaningful actions followed by their execution	Other: Experimental group; 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.; Other Names: AOT
Other: Control group; Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group	Other: Experimental group; 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.; Other Names: AOT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Box and Block Test	: it measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations from childhood to adults.	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	It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments	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	a semi-structured item-response questionnaire that measures manual ability according to an caregiver's perceived difficulty performing daily bimanual 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation and Environment Measure - Children and Youth (PEM-CY)	it is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.	Baseline (T0) and T3 (16 weeks after T2)
Cerebral Palsy Quality of Life Questionnaire	These instruments are useful for evaluating interventions designed to improve the lives of children and adolescents	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	The sensorized object allows to perform three different tasks at increasing level of difficulties (unimanual lifting, bimanual placing near and bimanual cooperation, holding and pulling)	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)
Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during AHA	Actigraph GXT3+ worn during AHA assessments	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 daily life activities detected with Actigraph GXT3+	Quantitative measurement of daily manual activities	During training and/or standard period (from T0 to T1 and/or T1 to T1plus) (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)

Collaborators and Investigators

• Sponsor: IRCCS Fondazione Stella Maris
• Collaborators: BioRobotics Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2017
• Primary Completion (Actual): October 29, 2018
• Study Completion (Actual): November 29, 2018

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): March 29, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 6, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Action Observation; ICT; Tele-rehabilitation; Mirror neurons
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Paralysis; Cerebral Palsy; Hemiplegia
• Other Study ID Numbers: GR-2011-02350053 AOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No