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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