Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610591
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Efficacy of Surgery for Idiopathic Toe Walking
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluating the Efficacy of Surgical Intervention for Idiopathic Toe Walking A Prospective Cohort Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FOREFOOT
Brief Summary:
BACKGROUND
For children who walk on their tip toes surgery is often done to lengthen their Achilles Tendon However there is little research to help childrens surgeons choose which children with idiopathic toe walking should have surgery
METHODS
This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking It will explore if the children39s quality of life endurance strength range of movement or walking pattern improves after they have had surgery
This study is a pilot study with 20 participants This means the results will be used to decide if a larger trial is needed
For children who walk on their tip toes surgery is often done to lengthen their Achilles Tendon However there is little research to help childrens surgeons choose which children with idiopathic toe walking should have surgery
METHODS
This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking It will explore if the children39s quality of life endurance strength range of movement or walking pattern improves after they have had surgery
This study is a pilot study with 20 participants This means the results will be used to decide if a larger trial is needed
Detailed Description:
BACKGROUND
It is common for children who learn to walk to walk on their tiptoes to help with their balance However approximately 7 of children will continue to walk on their toes past the age of three with no diagnosis to explain why This is called as idiopathic toe walking and can cause problems with balance pain and playing sports
For children with idiopathic toe walking who cannot touch their heels to the floor in standing surgery is often done to lengthen their Achilles Tendon This makes it easier to bend their foot towards their shin They should then be able to walk with their heels down in a more typical walking pattern
However this improvement is not always long-term Some children experience problems after surgery including weak legs There is little research to help childrens surgeons choose which children with idiopathic toe walking should have surgery
METHODS
This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking It will take part in two hospitals Oxford University Hospitals and St George39s Hospitals It will explore if the children39s quality of life endurance strength range of movement or walking pattern improves after they have had surgery This study is a pilot study This means it is a smaller trial with 20 participants The results will be used to decide if a larger trial is needed and how a larger trial should be run
The children in the study will be 8-16 years old with a tight Achilles Tendon who have been selected for surgery They will receive usual care This means their surgery will be no different than if they were not included in the study
The children will be given questionnaires with a maximum of 22 questions before surgery six months after surgery and one year after surgery They will also do a single heel-rise test before surgery and one year after surgery This will test if their calf muscle strength has changed after surgery They will also complete a computerised walking analysis before surgery and one year after surgery This will test if their walking pattern has changed after surgery They will also complete a satisfaction questionnaire one year after surgery This will ask about how satisfied they are with the surgery
It is common for children who learn to walk to walk on their tiptoes to help with their balance However approximately 7 of children will continue to walk on their toes past the age of three with no diagnosis to explain why This is called as idiopathic toe walking and can cause problems with balance pain and playing sports
For children with idiopathic toe walking who cannot touch their heels to the floor in standing surgery is often done to lengthen their Achilles Tendon This makes it easier to bend their foot towards their shin They should then be able to walk with their heels down in a more typical walking pattern
However this improvement is not always long-term Some children experience problems after surgery including weak legs There is little research to help childrens surgeons choose which children with idiopathic toe walking should have surgery
METHODS
This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking It will take part in two hospitals Oxford University Hospitals and St George39s Hospitals It will explore if the children39s quality of life endurance strength range of movement or walking pattern improves after they have had surgery This study is a pilot study This means it is a smaller trial with 20 participants The results will be used to decide if a larger trial is needed and how a larger trial should be run
The children in the study will be 8-16 years old with a tight Achilles Tendon who have been selected for surgery They will receive usual care This means their surgery will be no different than if they were not included in the study
The children will be given questionnaires with a maximum of 22 questions before surgery six months after surgery and one year after surgery They will also do a single heel-rise test before surgery and one year after surgery This will test if their calf muscle strength has changed after surgery They will also complete a computerised walking analysis before surgery and one year after surgery This will test if their walking pattern has changed after surgery They will also complete a satisfaction questionnaire one year after surgery This will ask about how satisfied they are with the surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None