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

NCT ID: NCT03856905

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-10
• Study Completion Date: 2019-06-10

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.

Detailed Description

Forty-five children with cerebral palsy (CP) with ages ranging from 6 to 9 years will participate in this study. They will be selected from the out-patient clinic of Obstetric and Pediatric Hospital, Comprehensive Rehabilitation Center, King Khalid Hospital and Najran Generalized Hospital, Najran, KSA, according to inclusive criteria including, 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. Exclusion criteria including, the use of botulinum toxin injection of the planter flexor muscles within the 4 months before the study and orthopedic surgery to the ankle joint in the previous 6 months before or during the study.

Children will be assigned randomly using opaque envelopes into three intervention groups (A, B and C). Group A will receive the conventional physical therapy program (CPTP) in addition to ankle foot orthosis (AFO). Group B will receive the CPTP, AFO in addition to Extra-corporeal shock wave therapy (ESWT), whereas group C will receive CPTP, AFO in addition to functional electrical stimulation (FES). All groups will receive the treatment program 3 sessions/week for 12 weeks. Evaluation of spasticity by using the MAS, function by using the pediatric functional independence scale and gait parameters by using the 3-dimensional gait analysis will be conducted before and after 12 weeks of the treatment program.

Conditions

Children With Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical therapy group

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.

Group Type: ACTIVE_COMPARATOR

Physical therapy program

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Physical therapy program

Intervention Type: 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.

Extracorporeal shock wave therapy

Intervention Type: 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.

Functional electrical stimulation group

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.

Group Type: EXPERIMENTAL

Physical therapy program

Intervention Type: 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.

Functional electrical stimulation

Intervention Type: 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.

Interventions

Physical therapy program

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.

Intervention Type: OTHER

Extracorporeal shock wave therapy

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.

Intervention Type: DEVICE

Functional electrical stimulation

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ahmed Mahmoud Eid

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy - Cairo University

Giza, , Egypt

Countries

Egypt

Other Identifiers

NU/MID/16/025

Identifier Type: -

Identifier Source: org_study_id