Extracorporeal Shock Wave Therapy Versus Functional Electrical Stimulation on Spasticity, Function and Gait Parameters in Hemiplegic Cerebral Palsy

NCT03856905 | Completed

• 1 other identifier: NU/MID/16/025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The purpose of this study will compare the effects of extracorporeal shock wave therapy (ESWT) versus functional electrical stimulation (FES) on spasticity, function and gait parameters in hemiplegic cerebral palsy (CP). Methods: Forty-five children with CP ranging in age from 6 to 9 years will be selected and will participate in this study. They will be assigned randomly using opaque envelopes into three groups (A, B and C). Group A will consist of 15 children and will receive the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group B will consist of 15 children and will receive the CPTP, AFO in addition to ESWT. Group C also will consist of 15 children and will receive the CPTP, AFO in addition to FES. The program of treatment will be 3 days/week for 12 weeks. Assessment of spasticity by using the modified ashworth scale (MAS), function by using the pediatric functional independence scale and gait parameters by using the 3-dimensional gait analysis will be conducted at baseline and after 12 weeks of the treatment program.

Conditions

Children With Cerebral Palsy

Keywords

Cerebral palsy; Extracorporeal Shock Wave Therapy; Functional Electrical Stimulation; Function; Gait; Spasticity

Outcome Measures

Primary Outcomes (6)

• Spasticity (assessing change between baseline and after treatment)

  Name of the scale: The Modified Ashworth Scale. It will be used to measure spasticity of the ankle plantar flexors. It is a simple measure of spasticity giving grades (0, 1, 1+, 2, 3, 4) 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension The total score will be obtained by calculating the mean of the obtained data Lower scores indicate better results.

  This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program

• Function (assessing change between baseline and after treatment)

  Name of the scale: Functional Independence Measure for Children It will be used to assess the functions of children between 6 months and 12 years. The scores of the scale extends from minimum 18 (fully dependent) to maximum 126 (fully independent) The scale measures different functional activities in children and the total score will be obtained for each category by computing the mean of the obtained data. Higher scores indicate better results.

  This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.

• Cadence (assessing change between baseline and after treatment)

  Cadence will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of cadence: steps/minute

  This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.

• Stride length (assessing change between baseline and after treatment)

  Stride length will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of Stride length: meter

  This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.

• Velocity (assessing change between baseline and after treatment)

  Velocity will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of velocity: meter/sec

  This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.

• Ankle dorsiflexion angle (assessing change between baseline and after treatment)

  Ankle dorsiflexion angle will be evaluated by using the 3-dimensional motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden). The unit of measure of Ankle dorsiflexion angle: degrees

  This outcome will be measured for each child before the beginning of treatment program and immediately after 12 weeks of the treatment program.

Study Arms (3)

Physical therapy group

ACTIVE COMPARATOR

The children in this group will receive the conventional physical therapy program (CPTP). It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neuro-developmental techniques, and gait training. The total program will be conducted for 1 h, three sessions/week for 12 weeks.

Other: Physical therapy program

Extra-corporeal shock wave therapy group

EXPERIMENTAL

The children in this group only will receive the extra-corporeal shock wave therapy (ESWT). An electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG) will be used. The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode, one session/week for 12 weeks. The treatment is painless and does not require any kind of anesthesia or the use of analgesic drugs

Other: Physical therapy program; Device: Extracorporeal shock wave therapy

Functional electrical stimulation group

EXPERIMENTAL

The children in this group will receive the functional electrical stimulation (FES). The FES will be applied by using the WalkAide system (Innovative Neurotronics, Austin, TX, USA). The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait.

Other: Physical therapy program; Device: Functional electrical stimulation

Interventions

Physical therapy program OTHER

It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neurodevelopmental techniques, and gait training.

Extra-corporeal shock wave therapy group; Functional electrical stimulation group; Physical therapy group

Extracorporeal shock wave therapy DEVICE

It is an electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG). The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode.

Extra-corporeal shock wave therapy group

Functional electrical stimulation DEVICE

It is a highly advanced medical device that consists of a battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads with a cuff holds the system in place. The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait.

Functional electrical stimulation group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children who demonstrate unilateral dynamic equinus deformity,
• All children must be ambulant independently and they will classified at Gross Motor Function Classification System (GMFCS) levels I or II,
• They must be free from any skeletal abnormalities other than spasticity and the degree of spasticity according to the Modified Ashworth Scale (MAS) within the range of 1+ and 2 grades,
• Moreover, all children must have a minimum five degrees of passive ankle dorsiflexion with knee joint extended

You may not qualify if:

• The use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study,
• Orthopedic surgery to the ankle joint in the previous 6 months before or during the study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy - Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2019
• First Posted: February 27, 2019
• Study Start: April 10, 2019
• Primary Completion: April 10, 2019
• Study Completion: June 10, 2019
• Last Updated: July 24, 2019

Record last verified: 2019-07

Locations

EG (1)