Efficacy of New Protocols in the Treatment of Upper Limb Dysfunctions in Patients With Cerebral Palsy

NCT03048851 | Completed DMC

• 1 other identifier: 103-7425A3
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Immediate and maintaining Efficacy of new protocols in the treatment of upper limb dysfunctions in patients with cerebral palsy.

Conditions

Cerebral Palsy

Keywords

Cerebral palsy; sensory electrical stimulation; virtual reality constraint-induced therapy

Outcome Measures

Primary Outcomes (1)

• change from baseline of muscle tone and basic motor abilities of the upper limb muscles in 12 and 24 weeks

  Muscle tone of the upper limb muscles assessment by Modified Ashworth Scale and Myoton (© 2011 Myoton AS.). Basic motor abilities included the assessments of the Bruininks-Oseretsky Test of Motor Proficiency II (BOT II), Melbourne Assessment 2 (MA2), Quality of upper extremity skills test (QUEST). The measure is a composite.

  baseline, 12weeks, 24weeks

Secondary Outcomes (8)

• change from baseline of quality of life in 12 and 24 weeks

  baseline, 12weeks, 24weeks

• change from baseline of activities of daily living (ADL) in 12 and 24 weeks

  baseline, 12weeks, 24weeks

• change from baseline of bone mineral density in 12 and 24 weeks

  baseline, 12weeks, 24weeks

• change from baseline of Metabolism and Body composition in 12 and 24 weeks

  baseline, 12weeks, 24weeks

• change from baseline of kinematic analysis in 12 and 24 weeks

  baseline, 12weeks, 24weeks

Study Arms (5)

Low dosage SES group

EXPERIMENTAL

Low dosage SES group received the low dosage SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.

Device: Low dosage SES group

High dosage SES group

EXPERIMENTAL

High dosage SES group received the high dosage SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.

Device: High dosage SES group

VRCIT group

EXPERIMENTAL

VRCIT group received the VRCIT training in addition to traditional rehabilitation.Each VRCIT session involved practice of functional tasks with the more affected UE followed by virtual-reality based eye-hand coordination tasks with the more affected UE for, in addition to home program, and restraint of the less affected UE for 1.5 hours per day.

Device: VRCIT group

VRCIT+SES group

EXPERIMENTAL

VRCIT+SES group received the VRCIT and SES training in addition to traditional rehabilitation.

Device: VRCIT+SES group

traditional rehabilitation group

ACTIVE COMPARATOR

Shame control group received the shame SES and traditional rehabilitation programs.

Procedure: traditional rehabilitation program

Interventions

Low dosage SES group DEVICE

The participants were randomly assigned to one of the five intervention groups. Low dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted twice per week, for 12 weeks. Each SES session involved electrical stimulation followed by UE training in addition to home program. The SES was applied to the forearm and whole hand with mesh glove (Electro-Mesh Glove-Sleeve Electrode Kit) for 45 minutes and arm with wrap for 45 minutes. The pulse width was set to 300us for all stimulation levels. The frequency was set to 100 Hz and 10 Hz.

Also known as: novel sensory electrical stimulation program

Low dosage SES group

High dosage SES group DEVICE

The participants were randomly assigned to one of the five intervention groups. High dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted twice per week, for 12 weeks. Each SES session involved electrical stimulation followed by UE training in addition to home program. The SES was applied to the forearm and whole hand with mesh glove (Electro-Mesh Glove-Sleeve Electrode Kit) for 90 minutes and arm with wrap for 90 minutes. The pulse width was set to 300us for all stimulation levels. The frequency was set to 100 Hz and 10 Hz.

Also known as: novel sensory electrical stimulation program

High dosage SES group

VRCIT group DEVICE

The participants were randomly assigned to one of the five intervention groups. VRCIT group received the VRCIT training plus traditional rehabilitation, conducted twice per week for 12 weeks. Each VRCIT session involved practice of functional tasks with the more affected UE followed by virtual-reality based eye-hand coordination tasks with the more affected UE for, plus home program, and restraint of the less affected UE for 1.5 hours per day. The functional training of the more affected UE focused on massive practice of functional activities using the more affected arm, with the principles of shaping and repetitive task practice applied during training. The VRCIT combined CIT and commercially available VR-based systems including Sony Playstation EyeToy and Nintendo Wii.

Also known as: virtual reality based Constraint-induced therapy

VRCIT group

VRCIT+SES group DEVICE

The participants were randomly assigned to one of the five intervention groups. VRCIT+SES group executed VR programs by affected UE in Mesh-gloves (Electro-Mesh Glove-Sleeve Electrode Kit) with the optimal SES (Micro-Z Mini, Prizm Medical Inc., USA) protocol formulated from the 1st phase study. The VRCIT program was conducted 1.5 hours/time, twice/week for 12 weeks. The VRCIT combined CIT and commercially available VR-based systems. Some commercially programs, such as Sony Playstation EyeToy (Sony Computer Entertainment America, Foster City, Calif., USA), and Nintendo Wii (Nintendo Domestic Distributor, College Point, N.Y., USA).

Also known as: combined VR based Constraint-induced therapy & SES

VRCIT+SES group

traditional rehabilitation program PROCEDURE

The participants were randomly assigned to one of the five intervention groups. The absence of muscle contractions was controlled by the investigator the sham stimulation was carried out identically, but the stimulation amplitude was set to 0 milliampere(mA). Subjects were not informed about the stimulation level and were instructed to distract attention from the stimulation.

traditional rehabilitation group

Eligibility Criteria

• Age: 2 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis with spastic CP with Gross Motor Function Classification System(GMFCS) levels I-IV
• Aged 2-24 years
• Ability to undergo clinical assessment
• Ability to comprehend commands and cooperate during an examination

You may not qualify if:

• Chromosomal abnormalities
• Progressive neurological disorder or severe concurrent illness or disease not typically associated with CP
• Active medical conditions such as pneumonia or poor physical conditions that would interfere with participation
• Any major surgery or nerve block in the preceding 3 months
• Metabolic or hormonal disturbance
• Cardiovascular disorder
• Poor tolerance or a poor cooperation during assessment

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chia-Ling Chen, MD,PhD

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: February 9, 2017
• Study Start: August 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: May 28, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)