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

NCT02039284 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-06-07

No results posted yet for this study

Summary

Cerebral palsy (CP) is the most common childhood motor disability. Weakness, spasticity, and loss of dexterity are the major problems in patients with CP. A novel virtual cycling training (VCT) program for lower limb was to enhance promising muscle strength through promoting the participant compliance and motivation. Sensory electrical stimulation(SES) of whole hand is a novel technique and is commonly used to treatment of spasticity for patients with stroke. Constraint-induced therapy (CIT) is a method for treating developmental disregard and learned non-use of affected limb and improving motor efficiency, functional performance, and activities of daily living for patients with CP.

Conditions

  • Cerebral Palsy

Interventions

DEVICE

SES

SES group received the SES 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 three times 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 for 20-30 minutes and arm with wrap for 20-30 minutes. The pulse width was set to 300 us for all stimulation levels. The frequency was set to 40-50 Hz.

DEVICE

VCT

The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body.

DEVICE

VRCIT

VRCIT group received the VRCIT training in addition to traditional rehabilitation, conducted three times 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, in addition to home program, and restraint of the less affected UE for 3.5 to 4 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.

DEVICE

traditional rehabilitation program

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.

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV
  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Chia-Ling Chen, MD,PhD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2018-01-31
Completion
2018-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039284 on ClinicalTrials.gov