NCT04554238

Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin

Completed NA Last updated 18 September 2020

What this trial tests

NA trial testing Armeo spring in Cerebral Palsy in 23 participants. Completed in 30 July 2019.

Timeline

1 November 2018

Primary endpoint
1 July 2019

30 July 2019

Quick facts

Lead sponsor	Sociedad Pro Ayuda del Niño Lisiado
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	23
Start date	1 November 2018
Primary completion	1 July 2019
Estimated completion	30 July 2019
Sites	1 location across Chile

Drugs / interventions tested

• Armeo spring
• Occupational Therapy

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →
• Upper Extremity Paresis — all drugs for Upper Extremity Paresis →

Sponsor

Sociedad Pro Ayuda del Niño Lisiado

Who can join

Adults 6 to 8, any sex, with Cerebral Palsy or Upper Extremity Paresis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Unilateral spastic cerebral palsy (CP) generates an impact on daily activities, mainly due to the functional limitation of the affected upper limb. The use of technologies such as Armeo spring robotic therapy seeks to improve upper limb mobility through innovative and motivating training that facilitates movement.

Objective: To assess the effectiveness of Armeo spring robotic therapy versus conventional occupational therapy regarding the changes in upper limb functionality of children with unilateral spastic CP infiltrated simultaneously with botulinum toxin A (BTA).

Patients and methods: Randomized clinical trial of parallel groups, in children between 4 and 10 years of age diagnosed with unilateral spastic CP and infiltrates with BTA, who received treatment of conventional occupational therapy (group I) or Armeo spring robotic therapy (group II). The intervention consists of 15 sessions of 40 minutes for 5 weeks, 3 times a week. An initial evaluation is applied with QUEST, ABILHAND-Kids, and MACS, which are re-evaluated at 3 and 6 months.

Hypothesis: Armeo spring robotic therapy will obtain better results than conventional occupational therapy in relation to the functionality of the upper limb at the level of manipulative function, quality of movement of the limb and the performance of daily activities.

Expected results: The results of the QUEST and ABILHAND-Kids dimensions assessed before, after and at follow-up will be the primary outcome. The presence of adverse effects will correspond to secondary outcome.

Benefit and limitations: Direct social contribution for patient's rehabilitation by using technology and a contribution to research to update scientific evidence. Possible limitations could be presence of adverse effects and poor adherence to treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.