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Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Casting of the lower limb and homebased stretching exercise program.
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring cerebral palsy, spastic cerebral palsy, stretching intervention, muscle morphology, range of motion, stiffness, spasticity

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Confirmed diagnosis of spastic cerebral palsy
  • Aged 4-12 years
  • GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment)
  • Sufficient cooperation to comprehend and complete the test procedure
  • Indication for casting of the lower limb

Exclusion Criteria:

  • Non-ambulatory
  • Botulinum toxin A injections six months prior to enrollment
  • Lower limb surgery two years prior to enrollment
  • Selective dorsal rhizotomy as treatment history
  • Presence of ataxia or dystonia
  • Cognitive problems that impede measurements
  • Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

This group will receive casting of the lower limb for approximately 2 weeks combined with a passive stretching program of the knee flexors, followed by a homebased stretching exercise program for the plantar flexors and hamstrings for 4 weeks after casting.

This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.

Outcomes

Primary Outcome Measures

Change in muscle belly and tendon length of the medial gastrocnemius and semitendinosus
Estimation of the muscle belly and tendon length by 3D freehand ultrasonography. The primary outcome will be the muscle belly/tendon length ratio.
Change of range of motion of the ankle and knee joint
Evaluation by an instrumented spasticity assessment
Change of range of motion of the ankle and knee joint
Evaluation by goniometry

Secondary Outcome Measures

Change in muscle neural (spasticity) and non-neural (stiffness) hyper-resistance
Evaluation of muscle spasticity and stiffness by an instrumented spasticity assessment
Change in functional muscle strength
Evaluation of functional muscle strength by the Adapted Functional Strength measure
Change in muscle echointensity
Estimation of the echointensity by 3D freehand ultrasonography
Change in muscle volume
Estimation of muscle volume by 3D freehand ultrasonography

Full Information

First Posted
December 18, 2020
Last Updated
May 21, 2021
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Queen Fabiola Children's University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04904094
Brief Title
Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
Official Title
Algorithms for Patient-specific Treatment Planning in Cerebral Palsy Based on the Muscle and Tendon Architecture - Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 1, 2022 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, University Ghent, Queen Fabiola Children's University Hospital

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
This study will investigate the effect of a 6-week stretching intervention, consisting of a combination of a 2-week casting period and a home-based stretching program of the plantar flexors and hamstrings, on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The study will include patients with spastic cerebral palsy aged between 4 and 11 years old with a Gross Motor Function Classification Score (GMFCS) level between I and III.
Detailed Description
This study will investigate the effect of a 6-week stretching intervention on muscle and tendon lengths, range of motion, stiffness, and functional muscle strength. The program consists of a 2-week casting period of the lower legs and a home-based stretching program of the hamstrings, followed by a 4-week stretching program of both the plantar flexors and hamstrings. The aim is twofold: (1) determine whether a 6-week stretching program for the plantar flexors and knee flexors leads to changes in the morphological muscle and tendon properties of the medial gastrocnemius and semitendinosus, ankle and knee range of motion, muscle strength, gait and gross motor function; and (2) determine the correlation between baseline morphological muscle and tendon properties and the changes in the primary outcome parameters (ankle range of motion and stiffness). The program will start with a 2-week period of stretching casts for the ankle plantar flexors, combined with a passive stretch program for the hamstrings, followed by a passive and active stretch program for both muscle groups for the remaining 4 weeks. The durations and frequencies for passive and active stretching are based on guidelines published by our own research group and on programs applied by previous research. The program will be set-up as a supervised home-based program on top of the usual care. The morphological muscle and tendon parameters, strength, spasticity, stiffness as well as gross motor function will be assessed before and after the entire 6-week stretching program. At the time of cast removal (after 2 weeks), only the morphological muscle and tendon parameters will be evaluated. This study includes an intervention and control group which will be group-matched based on diagnosis, GMFCS level and age. The study will include patients with spastic cerebral palsy between 4 and 11 years old and a GMFCS level between I and III. Thirty children with a clinical indication for casting of the lower limb will be included in the intervention group and 30 children without an indication for a specific intervention will be included in the control group. Children in the control group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
cerebral palsy, spastic cerebral palsy, stretching intervention, muscle morphology, range of motion, stiffness, spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will include patients who receive casting at the lower limb for the intervention group. Patient with no indication for treatment will be asked for participation in the control group. The children in the control group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This group will receive casting of the lower limb for approximately 2 weeks combined with a passive stretching program of the knee flexors, followed by a homebased stretching exercise program for the plantar flexors and hamstrings for 4 weeks after casting.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will continue their usual care or normal routine treatment, i.e. physiotherapy and orthotic devices.
Intervention Type
Other
Intervention Name(s)
Casting of the lower limb and homebased stretching exercise program.
Intervention Description
Lower leg casting in combination with removable upper leg casts for approximately 2 weeks and stretching exercises during casting and 4 weeks after casting.
Primary Outcome Measure Information:
Title
Change in muscle belly and tendon length of the medial gastrocnemius and semitendinosus
Description
Estimation of the muscle belly and tendon length by 3D freehand ultrasonography. The primary outcome will be the muscle belly/tendon length ratio.
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Title
Change of range of motion of the ankle and knee joint
Description
Evaluation by an instrumented spasticity assessment
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Title
Change of range of motion of the ankle and knee joint
Description
Evaluation by goniometry
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Secondary Outcome Measure Information:
Title
Change in muscle neural (spasticity) and non-neural (stiffness) hyper-resistance
Description
Evaluation of muscle spasticity and stiffness by an instrumented spasticity assessment
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Title
Change in functional muscle strength
Description
Evaluation of functional muscle strength by the Adapted Functional Strength measure
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Title
Change in muscle echointensity
Description
Estimation of the echointensity by 3D freehand ultrasonography
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.
Title
Change in muscle volume
Description
Estimation of muscle volume by 3D freehand ultrasonography
Time Frame
Between baseline, casting removal (2 to 4 weeks after baseline) and 6 to 8 weeks after baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis of spastic cerebral palsy Aged 4-12 years GMFCS levels I-III (GMFCS = Gross Motor Function Classification Score, expressing the overall functional level of impairment) Sufficient cooperation to comprehend and complete the test procedure Indication for casting of the lower limb Exclusion Criteria: Non-ambulatory Botulinum toxin A injections six months prior to enrollment Lower limb surgery two years prior to enrollment Selective dorsal rhizotomy as treatment history Presence of ataxia or dystonia Cognitive problems that impede measurements Severe co-morbidities (severe epilepsy, non-correctable visual impairment, autism spectrum disorders, mental problems that prevent comprehensiveness of the tasks)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicky Peeters
Phone
+3216341016
Email
nicky.peeters@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Uytterhoeven
Phone
+3216341016
Email
julie.uytterhoeven@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaat Desloovere, prof. dr.
Organizational Affiliation
KU Leuven
Official's Role
Study Director
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicky Peeters
Email
Nicky.peeters@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Kaat Desloovere, prof. dr.
Phone
+3216338009
Email
kaat.desloovere@kuleuven.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22549646
Citation
Franki I, Desloovere K, De Cat J, Feys H, Molenaers G, Calders P, Vanderstraeten G, Himpens E, Van Broeck C. The evidence-base for basic physical therapy techniques targeting lower limb function in children with cerebral palsy: a systematic review using the International Classification of Functioning, Disability and Health as a conceptual framework. J Rehabil Med. 2012 May;44(5):385-95. doi: 10.2340/16501977-0983.
Results Reference
background
PubMed Identifier
18728130
Citation
Lee GP, Ng GY. Effects of stretching and heat treatment on hamstring extensibility in children with severe mental retardation and hypertonia. Clin Rehabil. 2008 Sep;22(9):771-9. doi: 10.1177/0269215508090067.
Results Reference
background
PubMed Identifier
18834387
Citation
Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008 Oct;50(10):744-50. doi: 10.1111/j.1469-8749.2008.03089.x.
Results Reference
background
PubMed Identifier
16978468
Citation
Pin T, Dyke P, Chan M. The effectiveness of passive stretching in children with cerebral palsy. Dev Med Child Neurol. 2006 Oct;48(10):855-62. doi: 10.1017/S0012162206001836.
Results Reference
background
PubMed Identifier
24210836
Citation
Theis N, Korff T, Kairon H, Mohagheghi AA. Does acute passive stretching increase muscle length in children with cerebral palsy? Clin Biomech (Bristol, Avon). 2013 Nov-Dec;28(9-10):1061-7. doi: 10.1016/j.clinbiomech.2013.10.001. Epub 2013 Oct 10.
Results Reference
background
PubMed Identifier
28557247
Citation
van den Noort JC, Bar-On L, Aertbelien E, Bonikowski M, Braendvik SM, Brostrom EW, Buizer AI, Burridge JH, van Campenhout A, Dan B, Fleuren JF, Grunt S, Heinen F, Horemans HL, Jansen C, Kranzl A, Krautwurst BK, van der Krogt M, Lerma Lara S, Lidbeck CM, Lin JP, Martinez I, Meskers C, Metaxiotis D, Molenaers G, Patikas DA, Remy-Neris O, Roeleveld K, Shortland AP, Sikkens J, Sloot L, Vermeulen RJ, Wimmer C, Schroder AS, Schless S, Becher JG, Desloovere K, Harlaar J. European consensus on the concepts and measurement of the pathophysiological neuromuscular responses to passive muscle stretch. Eur J Neurol. 2017 Jul;24(7):981-e38. doi: 10.1111/ene.13322. Epub 2017 May 29.
Results Reference
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Homebased (6-week) Stretching Intervention in Children With Spastic Cerebral Palsy

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