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

Primary Purpose

Cerebral Palsy, Spastic, Hemiplegic Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Ankle-foot orthosis
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic focused on measuring spastic unilateral cerebral palsy, ankle-foot orthosis, AFO, muscle activity, muscular activity, electromyography, EMG,

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oslo University Hospital, RikshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CP participants

Arm Description

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.

Outcomes

Primary Outcome Measures

Muscle activity on/off times
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
Median frequency [uV] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.
Root-mean-square (RMS)
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
Average ankle angle [degrees] for each time interval the gait cycle is divided into.
Ankle moment, sagittal plane
Average moment [Nm] value for each time interval the gait cycle is divided into.

Full Information

First Posted
November 16, 2017
Last Updated
November 28, 2017
Sponsor
Oslo University Hospital
Collaborators
NITO, Norwegian engineering and technology organiziation, Sophies Minde
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1. Study Identification

Unique Protocol Identification Number
NCT03361930
Brief Title
Changes in Muscle Activity of Children With Spastic Unilat Cerebral Palsy Using 2 Types of Ankle-foot Orthoses to Walk
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
NITO, Norwegian engineering and technology organiziation, Sophies Minde

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Hemiplegic Cerebral Palsy
Keywords
spastic unilateral cerebral palsy, ankle-foot orthosis, AFO, muscle activity, muscular activity, electromyography, EMG,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CP participants
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Ankle-foot orthosis
Other Intervention Name(s)
AFO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle activity on/off times
Description
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.
Time Frame
30 minutes
Title
Median frequency
Description
Median frequency [uV] representing firing frequency for each muscle. Averaged for gait cycles from two trials for each condition.
Time Frame
30 minutes
Title
Root-mean-square (RMS)
Description
RMS to quantify difference in firing amplitude between conditions; normalized against resting RMS value for same muscle.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Ankle kinematic graph, sagittal plane
Description
Average ankle angle [degrees] for each time interval the gait cycle is divided into.
Time Frame
30 minutes
Title
Ankle moment, sagittal plane
Description
Average moment [Nm] value for each time interval the gait cycle is divided into.
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lærke Lindskov, B. Sc.
Phone
+4790875192
Email
laerli@ous-hf.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Britt Huse, M. Sc.
Organizational Affiliation
Oslo Universety Hospital, Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital, Rikshospitalet
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ann-Britt Huse, M. Sc.
Phone
+4799272061
Email
husann@ous-hf.no
First Name & Middle Initial & Last Name & Degree
Lærke Lindskov, B. Sc.
Phone
+4790875192
Email
laerli@ous-hf.no

12. IPD Sharing Statement

Learn more about this trial

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

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