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

Chang Gung Medical Foundation

Status: Completed

Conditions: Cerebral Palsy

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

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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