AOT and ICT for Hemiplegia (Tele-UPCAT)

• ClinicalTrials.gov Identifier: NCT03094455
• Recruitment Status: Completed
• First Posted: March 29, 2017
• Last Update Posted: August 7, 2019
• Sponsor: IRCCS Fondazione Stella Maris
• Collaborator: BioRobotics Institute
• Information provided by (Responsible Party): IRCCS Fondazione Stella Maris

Tracking Information

• First Submitted Date: March 16, 2017
• First Posted Date: March 29, 2017
• Last Update Posted Date: August 7, 2019
• Actual Study Start Date: March 29, 2017
• Actual Primary Completion Date: October 29, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 28, 2017)

Changes in the Assisting Hand Assessment [ Time Frame: 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) ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 23, 2017)

• Changes in Box and Block Test [ Time Frame: 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) ]
  : 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.
• Changes in Melbourne Assessment of Unilateral Upper Limb Function [ Time Frame: 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) ]
  It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments
• Changes in ABILHAND-kids [ Time Frame: 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) ]
  a semi-structured item-response questionnaire that measures manual ability according to an caregiver's perceived difficulty performing daily bimanual tasks.

Original Secondary Outcome Measures (submitted: March 28, 2017)

• Changes in Box and Block Test [ Time Frame: 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) ]
  : 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.
• Changes in Melbourne Assessment of Unilateral Upper Limb Function [ Time Frame: 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) ]
  It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments
• Changes in ABILHAND [ Time Frame: 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) ]
  a semi-structured item-response questionnaire that measures manual ability according to an individual's perceived difficulty performing daily bimanual tasks.

Current Other Pre-specified Outcome Measures (submitted: March 29, 2017)

• Participation and Environment Measure - Children and Youth (PEM-CY) [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
  it is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
• Cerebral Palsy Quality of Life Questionnaire [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
  These instruments are useful for evaluating interventions designed to improve the lives of children and adolescents
• Quantitative measurement of reaching and grasping capabilities by means of a sensorized object that allow different grasping tasks [ Time Frame: 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) ]
  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)
• Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during AHA [ Time Frame: 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) ]
  Actigraph GXT3+ worn during AHA assessments
• Changes in daily life activities detected with Actigraph GXT3+ [ Time Frame: 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) ]
  Quantitative measurement of daily manual activities

Original Other Pre-specified Outcome Measures (submitted: March 28, 2017)

• Participation and Environment Measure - Children and Youth (PEM-CY) [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
  it is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
• Cerebral Palsy Quality of Life Questionnaire [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
  These instruments are useful for evaluating interventions designed to improve the lives of children and adolescents
• Quantitative measurement of reaching and grasping capabilities by means of a sensorized object that allow different grasping tasks [ Time Frame: 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) ]
  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)
• Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during AHA [ Time Frame: 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) ]
  Actigraph GXT3+ worn during AHA assessments
• Changes in daily life activities detected with Actigraph GXT3+ [ Time Frame: 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) ]
  Quantitative measurement of daily manual activities

Descriptive Information

• Brief Title: AOT and ICT for Hemiplegia
• Official Title: Action-Observation Therapy (AOT) and Information and Communications Technologies (ICT) for Home Rehabilitation of Hemiplegia
• 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

It will be a parallel RCT with a waitlist design

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Condition

• Hemiplegia
• Hemiplegic Cerebral Palsy

Intervention

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 Name: AOT

Study Arms

• Experimental: Experimental group
  AOT is based on the observation of meaningful actions followed by their execution
  Intervention: Other: Experimental group
• Control group
  Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group
  Intervention: Other: Experimental group

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 6, 2019): 30
• Original Estimated Enrollment (submitted: March 28, 2017): 20
• Actual Study Completion Date: November 29, 2018
• Actual Primary Completion Date: October 29, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 20 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT03094455
• Other Study ID Numbers: GR-2011-02350053 AOT
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: IRCCS Fondazione Stella Maris
• Study Sponsor: IRCCS Fondazione Stella Maris
• Collaborators: BioRobotics Institute
• Investigators: Not Provided
• PRS Account: IRCCS Fondazione Stella Maris
• Verification Date: August 2019