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

Chang Gung Medical Foundation logo

Chang Gung Medical Foundation

Status

Completed

Conditions

Cerebral Palsy

Treatments

Device: VRCIT group
Device: Low dosage SES group
Device: High dosage SES group
Procedure: traditional rehabilitation program
Device: VRCIT+SES group

Study type

Interventional

Funder types

Other

Identifiers

NCT03048851
103-7425A3

Details and patient eligibility

About

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

Full 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).

Enrollment

125 patients

Sex

All

Ages

2 to 24 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

125 participants in 5 patient groups

Low dosage SES group
Experimental group
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.
Treatment:
Device: Low dosage SES group
High dosage SES group
Experimental group
Description:
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.
Treatment:
Device: High dosage SES group
VRCIT group
Experimental group
Description:
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.
Treatment:
Device: VRCIT group
VRCIT+SES group
Experimental group
Description:
VRCIT+SES group received the VRCIT and SES training in addition to traditional rehabilitation.
Treatment:
Device: VRCIT+SES group
traditional rehabilitation group
Active Comparator group
Description:
Shame control group received the shame SES and traditional rehabilitation programs.
Treatment:
Procedure: traditional rehabilitation program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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