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

Primary Purpose

Cerebral Palsy

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Low dosage SES group

High dosage SES group

VRCIT group

VRCIT+SES group

traditional rehabilitation program

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, sensory electrical stimulation, virtual reality constraint-induced therapy

Eligibility Criteria

2 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

Sites / Locations

Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Low dosage SES group

High dosage SES group

VRCIT group

VRCIT+SES group

traditional rehabilitation group

Arm Description

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.

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.

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.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

The health-related quality of life(HRQOL) assess by Cerebral Palsy Quality of Life (CP QOL) for Child and adolescent. The CP QOL is a measure of HRQOL specific to children and adolescent with cerebral palsy.

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

The ADL assessments included Functional Independence Measure for Children (WeeFIM) and Pediatric Motor Activity Log (PMAL). The measure is a composite.

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

he areal bone mineral density (aBMD) (g/cm2) will be measured at the lumbar spine (L1 to L4) and the humerus of the more-affected limb using dual X-ray absorptiometry (DXA).

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

The measure included the total energy expenditure (kcal/min), active energy expenditure (kcal/min), total number of steps, physical activity levels and duration, sleep duration and efficiency, weight, total body water, skeletal muscle mass (SMM), body fat mass (BFM), fat free mass, percent body fat, waist-hip ratio (WHR), and basal metabolic rate (BMR) by the devices of SenseWear(© 2013 BodyMedia, Inc.) and Body Composition Analyzer(InBody230). The measure is a composite.

change from baseline of kinematic analysis in 12 and 24 weeks

Kinematic analysis for patients performing Reach-to-grasp and Eye-hand coordination tasks.The measure is a composite.

change from baseline of muscle strength and endurance in 12 and 24 weeks

The device (Hoggan-5081) for kinetic analysis combined range of motion (ROM), muscle testing (MicroFET3) and grip and pinch gauge (MicroFET4) and data capture software, attached to a computer for more thorough testing. MicroFET4 combined pinch gauge and grip tester in a single device with high test-retest reliability. The Grip Test included Maximum Grip Test, 5 Position Grip Test, Rapid Exchange Grip Test, Hand Grip Fatigue Test. The Pinch Test included key Pinch, palmar Pinch, and tip pinch. MicroFET3 combined Muscle Tester and ROM Gauge. Peak force and average strength were obtained. The padded attachment that was fit in the palm of the hand allowed the administrators to provide direct resistance to movement of the extremity. For arm strength test, the examiner manually stabilized the body parts proximal to the tested limb segment during testing and asked participants to exert a maximal isometric muscle contraction lasting 3-seconds while the dynamometer was held stationary.

change from baseline of severity in 12 and 24 weeks

The severity is evaluated by Gross Motor Function Classification System(GMFCS), Manual Ability Classification System (MACS).The assessments for body function included Modified Ashworth Scale (MAS), strength, endurance, and trunk and limb involvement, etc. The measure is a composite.

change from baseline of reaction-time in 12 and 24 weeks

To examine the reaction time by CANTAB® software.

Full Information

NCT ID

NCT03048851

First Posted

October 10, 2016

Last Updated

May 27, 2020

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03048851

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 2015 (undefined)

Primary Completion Date

October 2019 (Actual)

Study Completion Date

October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

Cerebral palsy (CP) is the most common childhood motor disability. Spasticity and loss of dexterity are the major problems for motor disability of upper extremity (UE) in patients with CP. This study propose two novel treatment protocols: sensory electrical stimulation (SES) and virtual reality constraint-induced therapy (VRCIT) to improve function of UE in patients with CP. Investigators hypothesize that combined SES and VRCIT treatment have better effect than single therapy (SES or VRCIT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

125 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low dosage SES group

Arm Type

Experimental

Arm Description

Arm Title

High dosage SES group

Arm Type

Experimental

Arm Description

Arm Title

VRCIT group

Arm Type

Experimental

Arm Description

Arm Title

VRCIT+SES group

Arm Type

Experimental

Arm Description

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

Arm Title

traditional rehabilitation group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Low dosage SES group

Other Intervention Name(s)

novel sensory electrical stimulation program

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

High dosage SES group

Other Intervention Name(s)

novel sensory electrical stimulation program

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

VRCIT group

Other Intervention Name(s)

virtual reality based Constraint-induced therapy

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

VRCIT+SES group

Other Intervention Name(s)

combined VR based Constraint-induced therapy & SES

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

traditional rehabilitation program

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

baseline, 12weeks, 24weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

baseline, 12weeks, 24weeks

Title

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

Description

The ADL assessments included Functional Independence Measure for Children (WeeFIM) and Pediatric Motor Activity Log (PMAL). The measure is a composite.

Time Frame

baseline, 12weeks, 24weeks

Title

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

Description

he areal bone mineral density (aBMD) (g/cm2) will be measured at the lumbar spine (L1 to L4) and the humerus of the more-affected limb using dual X-ray absorptiometry (DXA).

Time Frame

baseline, 12weeks, 24weeks

Title

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

Description

Time Frame

baseline, 12weeks, 24weeks

Title

change from baseline of kinematic analysis in 12 and 24 weeks

Description

Kinematic analysis for patients performing Reach-to-grasp and Eye-hand coordination tasks.The measure is a composite.

Time Frame

baseline, 12weeks, 24weeks

Title

change from baseline of muscle strength and endurance in 12 and 24 weeks

Description

Time Frame

baseline, 12 weeks, 24 weeks

Title

change from baseline of severity in 12 and 24 weeks

Description

Time Frame

baseline, 12 weeks, 24 weeks

Title

change from baseline of reaction-time in 12 and 24 weeks

Description

To examine the reaction time by CANTAB® software.

Time Frame

baseline, 12 weeks ,24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chia-Ling Chen, MD,PhD

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Chang Gung Memorial Hospital

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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