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

NCT02039284 | Completed DMC

• 1 other identifier: 101-5261A3
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebral palsy; novel intervention; sensory electrical stimulation; virtual reality; cycling training; constraint-induced therapy; biomechanical; physiology; outcome

Outcome Measures

Primary Outcomes (2)

• change from baseline of muscle tone 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.).

  baseline, 12weeks, 24weeks

• change from baseline of Basic motor abilities in 12 and 24 weeks

  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, 12 weeks, 24 weeks

Secondary Outcomes (10)

• change from baseline of basic motor functions in 12 and 24 weeks

  baseline, 12weeks, 24weeks

• 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 participation in 12 and 24 weeks

  baseline, 12weeks, 24 weeks

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

  baseline, 12weeks, 24weeks

Study Arms (4)

SES group

EXPERIMENTAL

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.

Device: SES

VCT group

EXPERIMENTAL

VCT group received the VCT training in addition to traditional rehabilitation.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.

Device: VCT

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 3.5 to 4 hours per day.

Device: VRCIT

traditional rehabilitation group

ACTIVE COMPARATOR

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

Device: traditional rehabilitation program

Interventions

SES DEVICE

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.

Also known as: novel sensory electrical stimulation program

SES group

VCT DEVICE

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.

Also known as: The upper extremity programsvirtual cycling training program

VCT group

VRCIT DEVICE

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.

Also known as: virtual reality based Constraint-induced therapy

VRCIT group

traditional rehabilitation program DEVICE

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: 3 Years - 20 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 3-20 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
• National Science and Technology Council, Taiwan: collaborator

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: September 18, 2013
• First Posted: January 17, 2014
• Study Start: May 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 7, 2018

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)