Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study

Intensive Therapies in Children With Hemiplegia

Sponsors

Lead sponsor: University of Salamanca

Source University of Salamanca
Brief Summary

This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.

Detailed Description

the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

Overall Status Unknown status
Start Date May 3, 2018
Completion Date February 15, 2019
Primary Completion Date November 30, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
bimanual functional performance, "change" is being assessed 4 assessments will be carried out in the research in 10 weeks
Secondary Outcome
Measure Time Frame
quality of life ,"change" is being assessed 4 assessments will be carried out in the research in 10 weeks
Enrollment 40
Condition
Intervention

Intervention type: Combination Product

Intervention name: intensive therapies(CIMT/BIT): protocol 1 or protocol 2

Description: The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family

Eligibility

Criteria:

Inclusion Criteria:

- Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.

- Ages between 5 to 10 years.

- Levels of I-III within the , manual ability classification system, MACS.

- Levels of I-III within the gross motor function classification system, GMFCS

Exclusion Criteria:

- Diseases not associated with infantile hemiparesis.

- Low cognitive level to understand the execution of activities.

- Surgeries of the upper extremity during the 6 months prior to the intervention.

- Structured contractures in the affected upper extremity that cause functional impotence.

- Botulinum toxin two months prior to the intervention and application of it during the treatment.

- Epilepsy not controlled pharmacologically

Gender: All

Minimum age: 5 Years

Maximum age: 10 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Rocío Palomo Carrión Principal Investigator Salamanca University
Overall Contact

Last name: Rocío Palomo Carrión

Phone: 606417213

Email: [email protected]

Location
facility contact investigator Rocío Palomo Carrión Rocío Palomo Carrión 606417213 [email protected] Rocío Palomo Carrión Principal Investigator
Location Countries

Spain

Verification Date

March 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: University of Salamanca

Investigator full name: Rocío Palomo Carrión

Investigator title: physiotherapist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: low performance group 1

Arm group type: Experimental

Description: Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy

Arm group label: low performance group 2

Arm group type: Experimental

Description: Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy

Arm group label: moderate-high performance group1

Arm group type: Experimental

Description: Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy

Arm group label: moderate-high performance group 2

Arm group type: Experimental

Description: Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy

Acronym CIMT/BIT
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov