Download Trial Description

DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Trial Description
Title
Effects of stretching and treadmill training on equinus deformity
Trial Acronym
[---]*
URL of the trial
[---]*
Brief Summary in Lay Language
Cerebral Palsy (CP) is the consequence of a brain damage shortly before or after
birth. Amongst others, children suffer from spastic paresis and muscle
contractures. Equinus is the most common musculoskeletal impairment. Weak,
stiff and short calf muscles considerable constrain walking. Manual stretching of
contracted muscles is a longstanding part of physiotherapeutic treatment.
However, if and how muscles longitudinally adapt is subject to controversy.
Knowledge about the adaptive capacity of spastic muscle is rare, but may optimize
treatment strategies. Training that combines stretching with active muscle
contraction seems to be promising to induce muscle growth and promote
extensibility of the calf. In this regard, walking backward on an inclined treadmill
can be a repetitive method to stretch the active calf muscles in a functional
condition. Also motoric skills are expected to be trained.
The goal of this study is to compare the effects of therapeutic stretching with a
treadmill based therapy approach on calf muscle architecture and function in
children and youth with CP (n=12). Each participant is going to be treated with
manual stretching or treadmill training in two consecutive periods (each 9 weeks /
3x per w.). This study should provide knowledge, if stretching induces muscular
changes in the spastic calf which may also transfer to better walking skills. Calf
muscle architecture is going to be visualized by means of ultrasound scans while
walking will be captured by infrared-based motion capture technique. Besides,
motor function will be evaluated by standardized physiotherapeutic tests. It is
expected that both stretching and treadmill training will induce improvements,
but the latter will bring a larger gain.
Brief Summary in Scientific Language
Spastic equinus is one of the most common musculoskeletal impairments in
children with Cerebral Palsy (CP). Atrophied and stiff calf muscles limit joint
excursion and constrain walking. Active and static stretching is a longstanding
part of physiotherapeutic treatment. However, if and how muscles longitudinally
adapt is subject to controversy. Knowledge about the adaptive capacity of spastic
muscle-tendon units is vital. Eccentric muscle contraction at large muscle lengths
seem to be capable of promoting longitudinal muscle growth and also increase its
extensibility. Walking backward on an inclined treadmill can be a repetitive
method for eccentric muscle contractions of the calf in a functional condition. Also
motoric skills are expected to be trained.
Page 1 of 6
DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
The goal of this study is to compare the effects of therapeutic stretching with a
treadmill based therapy approach on architecture and function of the M.
Gastrocnemius medialis in children and youth with CP (n=12, 6-18 years, GMFCS III). Using a cross-over design, each participant is going to be treated with
stretching or treadmill training in two consecutive periods (each 9 weeks / 3x per
w.). In between treatment periods a 4 week washout phase will take place.
Primary outcomes are: 1) passive ankle joint flexibility; 2) morphology of the
medial Gastrocnemius (muscle length and fascicle length / Ultrasound); 3) passive
ankle joint stiffness (hand-held dynamometry); 4) ankle and knee joint kinematics
and kinetics during walking (3D gait analysis). Secondary outcomes are: 1)
modified Timed up and Go; 2) 1-minute walk-test; 3) GMFM-66 (dimension D&E); 4)
Mobques47. It is expected that both stretching and treadmill training will induce
improvements, but the latter will bring a larger gain.
Organizational Data
DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee Nr.: 2014-08 , Ethikkommission an der Physio-Akademie
GmbH
des Deutschen Verbandes für Physiotherapie (ZVK) e.V.
Wremer Specken 4
27638 Wremen
Secondary IDs
Health condition or Problem studied
ICD10: G80.1 - Spastic diplegic cerebral palsy
ICD10: G80.2 - Spastic hemiplegic cerebral palsy
Interventions/Observational Groups
Arm 1: Physiotherapeutic stretching of the calf - the therapy is scheduled over 9
weeks (3 times per week). One therapy unit lasts 45 min including breaks.
During each unit 7 manual or self-initiated static stretch exercises will be
conducted during standing, sitting or lying posture. End-position will be held
for 20 sec. For each leg, 5 repetitions will be executed.
Arm 2: Inclined backward walking on a treadmill - the therapy is scheduled over
Page 2 of 6
DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
9 weeks (3 times per week). One therapy unit lasts 45 min including breaks.
Each training consists of 3-4 walking bouts lasting for 5-10 min. Belt-speed will
be set at a comfortable pace. Belt-speed and decline will be gradually adjusted
during the 9 weeks.
Characteristics
Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: [---]*
Who is blinded: assessor
Control: Active control (effective treament of control group)
Purpose: Treatment
Assignment: Crossover
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): N/A
Primary Outcome
Before and after each block of therapy, altogether 4 measurement points:
1) passive ankle joint flexibility (dorsalextension);
2) Morphology of the medial Gastrocnemius (muscle length, thickness, fascicle
length / Ultrasound);
3) passive ankle joint stiffness, isometric force (handheld-dynamometry);
4) ankle and knee joint kinematics and kinetics during walking (3D gait Analysis)
All measurements are performed in the gait lab.
Secondary Outcome
Before and after each block of therapy, altogether 4 measurement points:
1) modified Timed up and Go Test: Time to raise from a chair, walk 3m, turn and
sit down again (gym)
2) 2-minute walk-test: Distance that can be covered within 2 minutes (gym)
3) GMFM-66 (dimension D&E): test battery of standing and walking tasks from
which motor function will be scored (gym)
4) mobility( Mobques47): questionnaire given to the parents.
Page 3 of 6
DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Countries of recruitment
DE Germany
Locations of Recruitment
Medical Center Orthopädische Kinderklinik BZ Aschau, Aschau
Recruitment
Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/01/07
Target Sample Size: 12
Monocenter/Multicenter trial: Monocenter trial
National/International: National
Inclusion Criteria
Gender: Both, male and female
Minimum Age: 6 Years
Maximum Age: 18 Years
Additional Inclusion Criteria
1) spastic CP;
2) age: 6-18 years;
3) Gross Motor Function Classification System I-II
Exclusion criteria
1)
2)
3)
4)
5)
6)
7)
inability to follow verbal instructions;
equinus with less than - 10° (lack) in passive dorsiflexion;
muscle tone >3 on modified Asworth scale;
corrective splints or cast < 3 months;
botulinum toxin injection < 6 months;
any soft-tissue surgery to the lower leg;
any orthopaedic surgeries < 12 Monate.
Addresses
Primary Sponsor
Page 4 of 6
DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Primary Sponsor
Behandlungszentrum Aschau GmbH nonprofit Organisation
Bernauerstr. 18
83229 Aschau i. Chiemgau
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Contact for Scientific Queries
Gait Laboratory Orthopaedic Hospital for Children Behandlungszentrum
Aschau GmbH nonprofit Organisation
Mr. MSc Matthias Hösl
Bernauerstr. 18
83229 Aschau i. Chiemgau
Germany
Telephone: +49 8052 1712016 (work)
Fax: [---]*
E-mail: m.hoesl at bz-aschau.de
URL: www.bz-aschau.de
Contact for Public Queries
Gait Laboratory Orthopaedic Hospital for Children Behandlungszentrum
Aschau GmbH nonprofit Organisation
Mr. MSc Matthias Hösl
Bernauerstr. 18
83229 Aschau i. Chiemgau
Germany
Telephone: +49 8052 1712016 (work)
Fax: [---]*
E-mail: m.hoesl at bz-aschau.de
URL: www.bz-aschau.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
Behandlungszentrum Aschau GmbH nonprofit Organisation
Bernauerstr. 18
83229 Aschau i. Chiemgau
Germany
Telephone: [---]*
Page 5 of 6
DRKS-ID: DRKS00006975
Date of Registration in DRKS: 2014/12/19
Date of Registration in Partner Registry or other Primary Registry: [---]*
Institutional budget, no external funding (budget of sponsor/PI)
Behandlungszentrum Aschau GmbH nonprofit Organisation
Bernauerstr. 18
83229 Aschau i. Chiemgau
Germany
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2015/07/31
Trial Publications, Results and other documents
Abstract Abstract
* This entry means the parameter is not applicable or has not been set.
Page 6 of 6