Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-09 @ 4:36 PM
Study NCT ID:
NCT03333434
Status:
TERMINATED
Last Update Posted:
2025-06-12
First Post:
2017-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Ankle-7 Orthosis VS HAFO Orthosis on Gait in Diplegic CPChildren
Sponsor:
Azienda USL Reggio Emilia - IRCCS
Organization:
Study Overview
Official Title:
Effectiveness of Ankle-7 Orthosis vs HAFO Orthosis on Gait Performance in Diplegic Cerebral Palsied Children
Status:
TERMINATED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties in recruiting
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ankle foot orthoses (AFO) are frequently used to improve locomotor skills of cerebral palsied children (CP) although the level of scientific evidence to support their use is still moderate. Carbon Ankle Seven spring (A7 - Otto Bock, Germany) is specifically designed to store energy when loaded and release it at toe-off in order to improve gait performance with respect to non-energy-storing AFOs. The aim of this work is to verify the superiority of the ankle-7 orthosis compared to the more widespread AFO, to improve the functionality and walking function of children with spastic diplegia and PCI.
Detailed Description:
The project is divided into the following phases:
T0 - at the beginning of the study children included will be subject to the following procedures and assessments:
1. demographic and anthropometric data collection;
2. randomization by concealed allocation to one of the following two groups:
* AFO - Ankle\_7 group
* Ankle-7 - AFO group Both, AFO and ankle-7, will be tailored to the patient
The two groups are distinguished by the order of the assignment of the two orthoses, respectively defined as the first assignment orthosis (O\_1) and second assignment orthosis (O\_2). The first group will use the orthoses AFO as a first assignment and then the orthoses Ankle\_7, while the second group will use the two orthoses according to the reverse order. The two will be used with the same orthotic footwear, with the exception of the cases where it will be necessary to change it due to accretion.
3. collection of the measures necessary for making the two orthotic devices at OttoBock of Reggio Emilia
4. training in the use of the orthoses according to a standardized protocol;
5. try on the patient's in-process first assignment orthoses (O\_1) and subsequent delivery of them (see Annex A);
Subsequently, the patient will use O\_1 for a period of 4-6 weeks.
T1 - patients will receive the following procedures and assessments:
1. try on the patient's in-process second assignment orthoses (O\_2)
2. instrumental gait analysis and video recording of the walking while using O\_1 (covered by elastic gaiters);
3. withdrawal of O\_1
4. delivery of O\_2 to the patient
Subsequently, the patient will use O\_2 for a period of 4-6 weeks.
T2 - patients will undergo the following procedures and evaluations:
1. instrumental gait analysis and video recording of the walking while using O\_2 (covered by elastic gaiters);
2. return of O\_1 to the patient;
3. Delivery of the diaries and directions for completing and mailing back them at the end of the follow-up period;
T3 - three months follow-up to detect the preference of use of AFO or Ankle-7 (by the child/parent)
T0 - at the beginning of the study children included will be subject to the following procedures and assessments:
1. demographic and anthropometric data collection;
2. randomization by concealed allocation to one of the following two groups:
* AFO - Ankle\_7 group
* Ankle-7 - AFO group Both, AFO and ankle-7, will be tailored to the patient
The two groups are distinguished by the order of the assignment of the two orthoses, respectively defined as the first assignment orthosis (O\_1) and second assignment orthosis (O\_2). The first group will use the orthoses AFO as a first assignment and then the orthoses Ankle\_7, while the second group will use the two orthoses according to the reverse order. The two will be used with the same orthotic footwear, with the exception of the cases where it will be necessary to change it due to accretion.
3. collection of the measures necessary for making the two orthotic devices at OttoBock of Reggio Emilia
4. training in the use of the orthoses according to a standardized protocol;
5. try on the patient's in-process first assignment orthoses (O\_1) and subsequent delivery of them (see Annex A);
Subsequently, the patient will use O\_1 for a period of 4-6 weeks.
T1 - patients will receive the following procedures and assessments:
1. try on the patient's in-process second assignment orthoses (O\_2)
2. instrumental gait analysis and video recording of the walking while using O\_1 (covered by elastic gaiters);
3. withdrawal of O\_1
4. delivery of O\_2 to the patient
Subsequently, the patient will use O\_2 for a period of 4-6 weeks.
T2 - patients will undergo the following procedures and evaluations:
1. instrumental gait analysis and video recording of the walking while using O\_2 (covered by elastic gaiters);
2. return of O\_1 to the patient;
3. Delivery of the diaries and directions for completing and mailing back them at the end of the follow-up period;
T3 - three months follow-up to detect the preference of use of AFO or Ankle-7 (by the child/parent)
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: