GaitTWNCT01208142
Toe Walker Gait Trial
A study testing Ankle Flexion Dynasplint in people with Gait, run by Dynasplint Systems, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Gait
- What is being tested?
- Ankle Flexion Dynasplint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2010to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Toe Walking secondary to CP
- Idiopathic TW
- Inability to ambulate with initial heel-contact
- Inability to bear weight and stand flat-footed for over one minute
- Inability to stand or hop on one foot (symptomatic) for more than one minute
Who cannot join
- Acid Maltase Deficiency Myopathy
- Acute Paralytic Poliomyelitis
- Spinal Muscular Atrophy-all types
- Stroke, ischemic or hemorrhagic, all types
- Multiple Sclerosis
- Traumatic Brain Injury (including Shaken Baby Syndrome)
Show all 10Show fewer
- Unilateral ROM deficits in Knee or Hip
- Previous Achilles Tendon lengthening surgery
- Hemiplegic Cerebral Palsy
- Muscular Dystrophy-all types
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Medical Center
Columbus, Ohio, 43210
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430
About this study
Official title: Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis
The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers.
For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.
- Conditions
- Gait
- Being tested
- standard of care treatment, Ankle Flexion Dynasplint
- Keywords
- toe walker, Pediatric toe walking, ankle flexion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of care treatmentOther
weekly standardized physical therapy and daily wear of an AFO
Ankle Flexion DynasplintDevice
Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | 25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO). Receives: Other: standard of care treatment |
| Dynasplint | Experimental | 25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint Receives: Device: Ankle Flexion Dynasplint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plantar flexion while ambulating
The primary endpoint or dependent variable of this study will be the change in excessive plantar flexion while ambulating. A repeated measures analysis of variance (ANOVA) will be performed to measure kinematic change in gait patterns calculated with an ambulation laboratory test.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2016 (estimated)
Why it stopped: Unrelated to trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for GaitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMurry University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208142
- Sponsor's protocol ID
- 2010.001
- Acronym
- TW
- Status last verified
- Aug 2013
- First submitted
- 22 Sep 2010
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lundequam P, Willis FB. Dynamic splinting home therapy for toe walking: a case report. Cases J. 2009 Nov 10;2:188. doi: 10.1186/1757-1626-2-188.
PubMed 19946498Booth MY, Yates CC, Edgar TS, Bandy WD. Serial casting vs combined intervention with botulinum toxin A and serial casting in the treatment of spastic equinus in children. Pediatr Phys Ther. 2003 Winter;15(4):216-20. doi: 10.1097/01.PEP.0000096382.65499.E2.
PubMed 17057457Li S, Bishop M, Sensac C. The Effect of Botulinium Toxin Type A Combined with Physical therapy on Gait in Children with idiopathic Toe Walking. Pediatric Physical Therapy. 2004 16(1):59.
Romkes J, Hell AK, Brunner R. Changes in muscle activity in children with hemiplegic cerebral palsy while walking with and without ankle-foot orthoses. Gait Posture. 2006 Dec;24(4):467-74. doi: 10.1016/j.gaitpost.2005.12.001. Epub 2006 Jan 18.
PubMed 16413188Brouwer B, Davidson LK, Olney SJ. Serial casting in idiopathic toe-walkers and children with spastic cerebral palsy. J Pediatr Orthop. 2000 Mar-Apr;20(2):221-5.
PubMed 10739286Mulligan H, Wilmshurst E. Physiotherapy assessment and treatment for an ambulant child with cerebral palsy after botox A to the lower limbs: a case report. Pediatr Phys Ther. 2006 Spring;18(1):39-48. doi: 10.1097/01.pep.0000202252.92562.4c.
PubMed 16508533Willis AW, Crowner B, Brunstrom JE, Kissel A, Racette BA. High dose botulinum toxin A for the treatment of lower extremity hypertonicity in children with cerebral palsy. Dev Med Child Neurol. 2007 Nov;49(11):818-22. doi: 10.1111/j.1469-8749.2007.00818.x.
PubMed 17979859Gage JR. The role of gait analysis in the treatment of cerebral palsy. J Pediatr Orthop. 1994 Nov-Dec;14(6):701-2. No abstract available.
PubMed 7814578Romkes J, Brunner R. Comparison of a dynamic and a hinged ankle-foot orthosis by gait analysis in patients with hemiplegic cerebral palsy. Gait Posture. 2002 Feb;15(1):18-24. doi: 10.1016/s0966-6362(01)00178-3.
PubMed 11809577Hicks R, Durinick N, Gage JR. Differentiation of idiopathic toe-walking and cerebral palsy. J Pediatr Orthop. 1988 Mar-Apr;8(2):160-3.
PubMed 3350949Galli M, Crivellini M, Santambrogio GC, Fazzi E, Motta F. Short-term effects of "botulinum toxin a" as treatment for children with cerebral palsy: kinematic and kinetic aspects at the ankle joint. Funct Neurol. 2001 Oct-Dec;16(4):317-23.
PubMed 11853322Ubhi T, Bhakta BB, Ives HL, Allgar V, Roussounis SH. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy. Arch Dis Child. 2000 Dec;83(6):481-7. doi: 10.1136/adc.83.6.481.
PubMed 11087280Hemo Y, Macdessi SJ, Pierce RA, Aiona MD, Sussman MD. Outcome of patients after Achilles tendon lengthening for treatment of idiopathic toe walking. J Pediatr Orthop. 2006 May-Jun;26(3):336-40. doi: 10.1097/01.bpo.0000217743.44609.44.
PubMed 16670545Weigl D, Copeliovitch L, Itzchak Y, Strauss S. Sonographic healing stages of Achilles tendon after tenomuscular lengthening in children with cerebral palsy. J Pediatr Orthop. 2001 Nov-Dec;21(6):778-83.
PubMed 11675554Gage JR. Gait analysis in cerebral palsy. London, Mac Keith Press; 1991
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Splinting for Toe Walking: a Randomized, Controlled Study With Gait Analysis
- ClinicalTrials.gov ID
- NCT01208142
- Acronym / sponsor ID
- TW / 2010.001
- Conditions
- Gait
- Keywords
- toe walker, Pediatric toe walking, ankle flexion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unrelated to trial
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- McMurry University
- Study start
- Sep 2010
- Primary completion
- Sep 2016 (estimated)
- First posted
- 23 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the change in ankle plantar flexion while walking, following treatment with the Ankle Dorsiflexion Dynasplint (AFD) for children diagnosed as Toe Walkers.
For twelve weeks, patients will either receive the standard treatment or the same standard treatment and the Dynaslint worn at night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: standard of care treatment25 Control subjects will only receive SOC (a weekly standardized physical therapy and daily wear of an AFO). |
| Dynasplint | Experimental | Device: Ankle Flexion Dynasplint25 Patients will receive the standard of care as well as an Ankle Flexion Dynasplint |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Toe Walking secondary to CP
- Idiopathic TW
- Inability to ambulate with initial heel-contact
- Inability to bear weight and stand flat-footed for over one minute
- Inability to stand or hop on one foot (symptomatic) for more than one minute
Key exclusion criteria (10 listed)
- Acid Maltase Deficiency Myopathy
- Acute Paralytic Poliomyelitis
- Spinal Muscular Atrophy-all types
- Stroke, ischemic or hemorrhagic, all types
- Multiple Sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of care treatmentweekly standardized physical therapy and daily wear of an AFO | Other | Standard of care |
| Ankle Flexion DynasplintWeekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint | Device | Dynasplint |
Primary outcome
Change in plantar flexion while ambulating
Time frame: 12 weeks
The primary endpoint or dependent variable of this study will be the change in excessive plantar flexion while ambulating. A repeated measures analysis of variance (ANOVA) will be performed to measure kinematic change in gait patterns calculated with an ambulation laboratory test.
Results and safety
The study was stopped early (reason given: Unrelated to trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Background: PubMed 19946498Lundequam P, Willis FB. Dynamic splinting home therapy for toe walking: a case report. Cases J. 2009 Nov 10;2:188. doi: 10.1186/1757-1626-2-188.
- Background: PubMed 17057457Booth MY, Yates CC, Edgar TS, Bandy WD. Serial casting vs combined intervention with botulinum toxin A and serial casting in the treatment of spastic equinus in children. Pediatr Phys Ther. 2003 Winter;15(4):216-20. doi: 10.1097/01.PEP.0000096382.65499.E2.
- BackgroundLi S, Bishop M, Sensac C. The Effect of Botulinium Toxin Type A Combined with Physical therapy on Gait in Children with idiopathic Toe Walking. Pediatric Physical Therapy. 2004 16(1):59.
- Background: PubMed 16413188Romkes J, Hell AK, Brunner R. Changes in muscle activity in children with hemiplegic cerebral palsy while walking with and without ankle-foot orthoses. Gait Posture. 2006 Dec;24(4):467-74. doi: 10.1016/j.gaitpost.2005.12.001. Epub 2006 Jan 18.
- Background: PubMed 10739286Brouwer B, Davidson LK, Olney SJ. Serial casting in idiopathic toe-walkers and children with spastic cerebral palsy. J Pediatr Orthop. 2000 Mar-Apr;20(2):221-5.
- Background: PubMed 16508533Mulligan H, Wilmshurst E. Physiotherapy assessment and treatment for an ambulant child with cerebral palsy after botox A to the lower limbs: a case report. Pediatr Phys Ther. 2006 Spring;18(1):39-48. doi: 10.1097/01.pep.0000202252.92562.4c.
- Background: PubMed 17979859Willis AW, Crowner B, Brunstrom JE, Kissel A, Racette BA. High dose botulinum toxin A for the treatment of lower extremity hypertonicity in children with cerebral palsy. Dev Med Child Neurol. 2007 Nov;49(11):818-22. doi: 10.1111/j.1469-8749.2007.00818.x.
- Background: PubMed 7814578Gage JR. The role of gait analysis in the treatment of cerebral palsy. J Pediatr Orthop. 1994 Nov-Dec;14(6):701-2. No abstract available.
- Background: PubMed 11809577Romkes J, Brunner R. Comparison of a dynamic and a hinged ankle-foot orthosis by gait analysis in patients with hemiplegic cerebral palsy. Gait Posture. 2002 Feb;15(1):18-24. doi: 10.1016/s0966-6362(01)00178-3.
- Background: PubMed 3350949Hicks R, Durinick N, Gage JR. Differentiation of idiopathic toe-walking and cerebral palsy. J Pediatr Orthop. 1988 Mar-Apr;8(2):160-3.
- Background: PubMed 11853322Galli M, Crivellini M, Santambrogio GC, Fazzi E, Motta F. Short-term effects of "botulinum toxin a" as treatment for children with cerebral palsy: kinematic and kinetic aspects at the ankle joint. Funct Neurol. 2001 Oct-Dec;16(4):317-23.
- Background: PubMed 11087280Ubhi T, Bhakta BB, Ives HL, Allgar V, Roussounis SH. Randomised double blind placebo controlled trial of the effect of botulinum toxin on walking in cerebral palsy. Arch Dis Child. 2000 Dec;83(6):481-7. doi: 10.1136/adc.83.6.481.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Flexion Dynasplint in people with Gait, run by Dynasplint Systems, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unrelated to trial). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plantar flexion while ambulating (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01208142, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013; AzTrials last refreshed its copy on 27 Oct 2026.