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Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk

This study is currently recruiting participants.
Verified November 2017 by Ann-Britt Huse, Oslo University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03361930
First Posted: December 5, 2017
Last Update Posted: December 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
NITO, Norwegian engineering and technology organiziation
Sophies Minde
Information provided by (Responsible Party):
Ann-Britt Huse, Oslo University Hospital
  Purpose

The aim of this study is to investigate if ankle-foot orthoses affect changes in muscle activity of children with spastic unilateral cerebral palsy during walking.

To minimize investigator variability, the same orthotist CO, clinical gait analyst GA and physiotherapist PT will perform their designated functions for all participants.

Each subject will be required to attend three appointments.

First appointment: CO takes a lower leg cast of the involved side; the cast is taken with the ankle and hindfoot corrected to neutral position.

Second appointment: CO fits the tone-reducing ankle-foot orthosis which entails trimming the device to fit footwear, checking the orthotic device restricts plantarflexion and ensuring comfortable and functional fit. The device is modified with holes for electrode placement at locations for tibialis anterior and gastrocnemius identified by PT.

The child receives the tone-reducing ankle-foot orthosis and is instructed to use this orthotic device on a daily basis for the next four weeks to grow accustomed to the tone-reducing stimuli which may require some acclimatization.

Third appointment: A clinical examination is conducted by PT. Surface gel electrodes are then attached while the participant is instructed in individual muscle activation tests; SENIAM guidelines will be followed for electrode placement and skin preparation, aside from hamstrings and rectus femoris which will follow amended instructions in line with the scientific literature.

GA quality checks the raw electromyography (EMG) signals by visual inspection during the isolated muscle activation tests and during a dynamic trial for movement artefacts, cross-talk, baseline drift and good noise-to-signal ratio.

Reflective markers are then applied in accordance with Plug-in Gait lower body model by PT to collect kinematic and kinetic data.

A resting trial is collected to establish the baseline activity level for each muscle.

The participant is instructed to walk at a self-selected speed along the walkway. Dynamic trials continue until two clean strikes to the middle force plate are collected for the involved leg. Barefoot data is collected first while any additional modifications necessary for electrode placement are made to the ankle-foot orthoses. The order of the orthotic conditions is randomized.

Data will be recorded confidentially using reference codes for participants and stored on a secure server with designated space allocated by the hospital.


Condition Intervention
Cerebral Palsy, Spastic Hemiplegic Cerebral Palsy Device: Ankle-foot orthosis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Electromyographic Comparison of Muscle Activity in Children With Spastic Unilateral Cerebral Palsy During Walking With Two Different Types of Hinged Ankle-foot Orthoses

Resource links provided by NLM:


Further study details as provided by Ann-Britt Huse, Oslo University Hospital:

Primary Outcome Measures:
  • Muscle activity on/off times [ Time Frame: 30 minutes ]
    Linear electromyography profiles of muscle activity (high-pass filtered, rectified and low-pass enveloped) for medial gastrocnemius, tibialis anterior, medial hamstrings, rectus femoris and vastus lateralis during walking. For each condition, gait cycles from two trials will be averaged. Signals will be synchronized to the gait cycle by foot contact/foot off events and normalized to max dynamic peak. On/off times will be defined as a percentage of max dynamic peak.

  • Median frequency [ Time Frame: 30 minutes ]
    Median frequency [uV] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.

  • Root-mean-square (RMS) [ Time Frame: 30 minutes ]
    RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.


Secondary Outcome Measures:
  • Ankle kinematic graph, sagittal plane [ Time Frame: 30 minutes ]
    Average ankle angle [degrees] for each time interval the gait cycle is divided into.

  • Ankle moment, sagittal plane [ Time Frame: 30 minutes ]
    Average moment [Nm] value for each time interval the gait cycle is divided into.


Estimated Enrollment: 20
Actual Study Start Date: October 19, 2017
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CP participants
Single-day data collection for walking conditions; barefoot, with plain ankle-foot orthosis (flat foot plate) on involved side, with tone-reducing ankle-foot orthosis on involved side.
Device: Ankle-foot orthosis

Two custom ankle-foot orthoses for the involved lower leg; cast, rectified and fitted by same certified orthotist to reduce clinician variability.

The cast is rectified according to the specifications of Hylton (1987) to produce tone-reducing features in the foot plate; the tone-reducing ankle-foot orthosis is manufactured on this cast. The orthotist then remodels the cast with a flat foot plate; the plain ankle-foot orthosis is then manufactured.

Other Name: AFO

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Spastic unilateral cerebral palsy (hemiplegic)
  • Use of an ankle-foot orthosis (AFO) during walking because of equinus in the ankle,
  • Excessive plantarflexion during walking
  • Gross Motor Function Classification System (GMFCS) I or II

Exclusion criteria:

  • Orthopedic surgery on the involved lower limb during the previous 12 months
  • Treated with BTX-a in muscles of the involved lower limb during the previous 6 months
  • Operated with selective dorsal rhizotomy (SDR)
  • Passive dorsiflexion in the ankle, passive extension of the knee and hip < 0 degrees (no fixed contractures)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03361930


Contacts
Contact: Lærke Lindskov, B. Sc. +4790875192 laerli@ous-hf.no

Locations
Norway
Oslo University Hospital, Rikshospitalet Recruiting
Oslo, Norway, 0424
Contact: Ann-Britt Huse, M. Sc.    +4799272061    husann@ous-hf.no   
Contact: Lærke Lindskov, B. Sc.    +4790875192    laerli@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
NITO, Norwegian engineering and technology organiziation
Sophies Minde
Investigators
Principal Investigator: Ann-Britt Huse, M. Sc. Oslo Universety Hospital, Oslo, Norway
  More Information

Responsible Party: Ann-Britt Huse, Principal investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03361930     History of Changes
Other Study ID Numbers: 2017/161
First Submitted: November 16, 2017
First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ann-Britt Huse, Oslo University Hospital:
spastic unilateral cerebral palsy, ankle-foot orthosis, AFO, muscle activity, muscular activity, electromyography, EMG,

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Muscle Spasticity
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations