Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle
Primary Purpose
Cerebral Palsy, Spastic
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Stretching through immobilisation (IG)
Stretching through immobilisation and activity (IAG)
Control Phase
Sponsored by
About this trial
This is an interventional basic science trial for Cerebral Palsy, Spastic
Eligibility Criteria
Inclusion Criteria:
- Ambulatory children with spastic CP.
- Ability to accept and follow verbal instruction.
- Limited range of motion in ankle joint - maximal dorsiflexion with knee extended ≤ 5°
- Gross Motor Functional Classification System level I-III.
- Age 5-15 years.
- Willingness to participate.
Exclusion Criteria:
- Other than spastic form of CP (ataxic, athetoid or dystonic).
- Severe mental retardation.
- Normal range of motion in ankle joint
- Oral antispastic or muscle relaxing medication.
- History of orthopaedic surgery in the last 12 months.
- History of botulinum toxin type A application in the last six months.
Sites / Locations
- Medical University GrazRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Other
Arm Label
Immobilization group (IG)
Immobilization/Activity Group (IAG)
Control Phase
Arm Description
One group - immobilization group (IG) - will receive the standard treatment.
The other group - Immobilization/Activity Group (IAG) - will be treated with a new approach.
Before the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned.
Outcomes
Primary Outcome Measures
Change in mechano-morphological muscle-tendon properties - muscle volume
Gastrocnemius medialis muscle volume
Change in mechano-morphological muscle-tendon properties - fascile length
Gastrocnemius medialis fascile length
Change in mechano-morphological muscle-tendon properties - unit length
Gastrocnemius medialis muscle belly, tendon and muscle-tendon unit length
Change in mechano-morphological muscle-tendon properties - elongation
Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit elongation due to externally applied torque to the ankle joint [elongation in mm]
Change in mechano-morphological muscle-tendon properties - stiffness
Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit stiffness due to externally applied torque to the ankle joint [stiffness in N/mm]
Change in joint range of motion
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Change in maximal isometric muscle strength
Maximal isometric torque production (isokinetic dynamometry)
Change in gait characteristics
Gait kinematics (joint angles [°]) and kinetics (joint moments [Nm/kg]) of the hip, knee, and ankle joints (3D motion capture). Joint angles [°] and moments [Nm/kg] will be combined to report changes in gait pattern.
Secondary Outcome Measures
Change in self-reported gait, mobility, and functional performance - GOAL
Gait Outcomes Assessment List (GOAL) Questionnaire
Change in self-reported gait, mobility, and functional performance - PODCI
Pediatrics Outcomes Data Collection Instrument (PODCI) Questionnaire
Full Information
NCT ID
NCT05269745
First Posted
February 14, 2022
Last Updated
July 11, 2022
Sponsor
Medical University of Graz
Collaborators
University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT05269745
Brief Title
Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle
Official Title
Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Neurologic changes caused by cerebral palsy (CP) result in adaptation of muscle architecture and function (e.g. shortened muscles and contractures). Stretching through immobilization (orthotic treatment) is one of the common interventions to bring the spastic muscle to growth. Positive outcomes of stretching through immobilization are increased range of motion and improved function. On the other hand, immobilization leads to disuse muscle atrophy. Hence, we hypothesize that combining a stretching through immobilization and muscle activity while controlling for foot deformity could be a superior treatment approach, which should lead to improved muscle morphology as well as function. The aim of the study is to examine the influence of two orthotic treatments (a standard regime and one new approach) on spastic plantar flexor muscles in children and adolescents with CP. The standard regime (stretching through immobilisation) includes a dynamic AFO (ankle-foot orthosis) used during day and night. The new approach combines stretching through immobilisation and allows for plantarflexor activity due to an innovative construction of the orthotic device.
This prospective randomized controlled study will recruit 20 ambulant children and adolescents (aged 5 to 15 years) with cerebral palsy and equinus deformity (GMFCS = Gross Motor Function Classification System level I to III). Each child will be randomized and stratified according to age and GMFCS to one of two groups. The first group receives the standard treatment (stretching through immobilization) using custom-made ankle foot orthosis for 23 hours per day. The other group will be treated with the same orthosis at night (8 hours) and for 6 hours during the day but the remaining 10 hours will be treated with the foot shell only that corrects subtalar and Chopart joints but does not block the ankle joint movement, so that more activity of plantarflexors will be possible during the day. The intervention will last for 12 weeks. Each child will be examined at four occasions (8 weeks before intervention = control phase, at the beginning of the intervention and then 8 and 12 weeks later). The main outcome measure is the fascicle length measured using a 3D ultrasound (3DUS) imaging technique. Further parameters of interest span across the whole levels of ICF including clinical examinations, biomechanics of gait, muscle morphologic and mechanic properties and participations questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Immobilization group (IG)
Arm Type
Active Comparator
Arm Description
One group - immobilization group (IG) - will receive the standard treatment.
Arm Title
Immobilization/Activity Group (IAG)
Arm Type
Experimental
Arm Description
The other group - Immobilization/Activity Group (IAG) - will be treated with a new approach.
Arm Title
Control Phase
Arm Type
Other
Arm Description
Before the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned.
Intervention Type
Other
Intervention Name(s)
Stretching through immobilisation (IG)
Other Intervention Name(s)
IG
Intervention Description
The immobilization group (IG) will receive the standard treatment, a dynamic ankle-foot orthosis (AFO) for night and day use (23 hours per day)
Intervention Type
Other
Intervention Name(s)
Stretching through immobilisation and activity (IAG)
Other Intervention Name(s)
IAG
Intervention Description
The Immobilization/Activity Group (IAG) will be treated with the same type of ankle-foot orthosis at night (8 hours) and for 6 hours during the day (altogether orthosis treatment 14 hours per day). The rest of the day (10 hours) children and adolescents will be using only the foot shell of orthoses (FS) without the lower leg shell, to secure the correct position of the foot and to allow a free motion at ankle joint with a good correction of the foot deformity (e.g. Pes equinovarus / equinovalgus, midfoot-break).
Intervention Type
Other
Intervention Name(s)
Control Phase
Intervention Description
Before the intervention with the orthotic treatment starts, a control phase of 8 weeks is planned. During this time, the individual orthoses for each subject are manufactured.
Primary Outcome Measure Information:
Title
Change in mechano-morphological muscle-tendon properties - muscle volume
Description
Gastrocnemius medialis muscle volume
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in mechano-morphological muscle-tendon properties - fascile length
Description
Gastrocnemius medialis fascile length
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in mechano-morphological muscle-tendon properties - unit length
Description
Gastrocnemius medialis muscle belly, tendon and muscle-tendon unit length
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in mechano-morphological muscle-tendon properties - elongation
Description
Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit elongation due to externally applied torque to the ankle joint [elongation in mm]
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in mechano-morphological muscle-tendon properties - stiffness
Description
Passive gastrocnemius medialis muscle belly, tendon and muscle-tendon unit stiffness due to externally applied torque to the ankle joint [stiffness in N/mm]
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in joint range of motion
Description
Ankle joint range of motion (maximal plantarflexion - maximal dorsiflexion)
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in maximal isometric muscle strength
Description
Maximal isometric torque production (isokinetic dynamometry)
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in gait characteristics
Description
Gait kinematics (joint angles [°]) and kinetics (joint moments [Nm/kg]) of the hip, knee, and ankle joints (3D motion capture). Joint angles [°] and moments [Nm/kg] will be combined to report changes in gait pattern.
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Secondary Outcome Measure Information:
Title
Change in self-reported gait, mobility, and functional performance - GOAL
Description
Gait Outcomes Assessment List (GOAL) Questionnaire
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
Title
Change in self-reported gait, mobility, and functional performance - PODCI
Description
Pediatrics Outcomes Data Collection Instrument (PODCI) Questionnaire
Time Frame
Time Frame: baseline (T1), PRE-measurement (T2, 8 weeks), POST-measurement (T3, 16 weeks), FOLLOW-UP measurement (T4, 20 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ambulatory children with spastic CP.
Ability to accept and follow verbal instruction.
Limited range of motion in ankle joint - maximal dorsiflexion with knee extended ≤ 5°
Gross Motor Functional Classification System level I-III.
Age 5-15 years.
Willingness to participate.
Exclusion Criteria:
Other than spastic form of CP (ataxic, athetoid or dystonic).
Severe mental retardation.
Normal range of motion in ankle joint
Oral antispastic or muscle relaxing medication.
History of orthopaedic surgery in the last 12 months.
History of botulinum toxin type A application in the last six months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Habersack, BSc MSc
Phone
+433163803904
Email
andreas.habersack@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Svehlik, MD PhD
Phone
+4331638514129
Email
martin.svehlik@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Habersack, BSc MSc
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Svehlik, MD PhD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Svehlik, MD PhD
Phone
+4331638514129
Email
martin.svehlik@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Andreas Habersack, BSc MSc
First Name & Middle Initial & Last Name & Degree
Martin Svehlik, MD PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
It is yet not decided if individual data will be shared with other researchers.
Learn more about this trial
Influence of Immobilisation, Stretching and Activity on Morphological and Mechanical Properties of Spastic Muscle
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