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Completed

NCT Number: NCT03094455

AOT and ICT for 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.

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Key information

Conditions

Hemiplegia Hemiplegic Cerebral Palsy Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

About this study

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

  • Immediate intervention group (Experimental group). Children will receive immediately the system for 3 weeks.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: AOT

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

Other outcomes

  1. 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.

  2. 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

  3. 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)

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Collaborators

  • BioRobotics Institute

Registry information

Official study title

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

Acronym: Tele-UPCAT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 29, 2017
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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