Foot Sensory DeficitPhase 1/2WALKAIDENCT02639689
Evaluation of the Increase of the Driving Speed With Walkaide® Medical Device
A Phase 1/2 study testing WALKAIDE in people with Foot Sensory Deficit, run by University Hospital, Angers at 1 site in France.
Trial summary
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Foot Sensory Deficit
- What is being tested?
- WALKAIDE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2013to Jan 2016
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Passive ankle dorsiflexion of at least 0 ° (strained knee)
- No injection of botulinum toxin in the lower limbs for at months 3 months
- No surgery for at least three months
- Walk 10 meters in less than 60 seconds, without human help, with or without technical assistance
- Score the Functional Ambulation Classification (FAC) ≥ 3
- Ashworth Score ≤ 2 sural triceps
- Written consent signed
Who cannot join
- Presence of severe cognitive impairment that does not allow the use of the device independently
- History of debilitating disease associated general
- Local embarrassing skin disorder laying the electrodes
- Pacemaker
- Unstable Epilepsy
- Pregnancy and lactation
- Participation Refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Les Capucins
Angers, Pays de la Loire Region, 49103
Isabelle PI Richard-Crémieux, Md-PHD, 02 41 35 17 19 ext. 33, Isabelle.richard@univ-angers.fr
Flavie IV Frémondière, MD, 02 31 35 17 06 ext. 33, flaviefremondiere@yahoo.fr
About this study
Official title: Evaluation of the Increase of the Driving Speed After the Apparatus by Walkaide® Medical Device in Deficits Levator Foot of Central Origin.
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.
Read the detailed description
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotic and walking with orthotic Walkaide® medical devie after one month of training.
This is a prospective multicenter study, without control group, qualified as a biomedical research.
- Conditions
- Foot Sensory Deficit
- Being tested
- WALKAIDE
- Keywords
- Deficits of foot relievers of central origin, Walkaide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WALKAIDEDevice
A clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device.
Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device.
| Study group | Role | What they receive |
|---|---|---|
| WALKAIDE | Experimental | A clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device.
Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device. Receives: Device: WALKAIDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotics and walking with Walkaide® functionnal electric stimulation orthosis after one month of training.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2016 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Foot Sensory DeficitStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Isabelle Richard, md-PHD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639689
- Sponsor's protocol ID
- CHU PROMOTEUR 2013/12
- Acronym
- WALKAIDE
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67. doi: 10.1177/1545968309347681. Epub 2009 Oct 21.
PubMed 19846759Detrembleur C, Dierick F, Stoquart G, Chantraine F, Lejeune T. Energy cost, mechanical work, and efficiency of hemiparetic walking. Gait Posture. 2003 Oct;18(2):47-55. doi: 10.1016/s0966-6362(02)00193-5.
PubMed 14654207Kottink AI, Oostendorp LJ, Buurke JH, Nene AV, Hermens HJ, IJzerman MJ. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Artif Organs. 2004 Jun;28(6):577-86. doi: 10.1111/j.1525-1594.2004.07310.x.
PubMed 15153151Everaert DG, Thompson AK, Chong SL, Stein RB. Does functional electrical stimulation for foot drop strengthen corticospinal connections? Neurorehabil Neural Repair. 2010 Feb;24(2):168-77. doi: 10.1177/1545968309349939. Epub 2009 Oct 27.
PubMed 19861590Sabut SK, Lenka PK, Kumar R, Mahadevappa M. Effect of functional electrical stimulation on the effort and walking speed, surface electromyography activity, and metabolic responses in stroke subjects. J Electromyogr Kinesiol. 2010 Dec;20(6):1170-7. doi: 10.1016/j.jelekin.2010.07.003. Epub 2010 Aug 6.
PubMed 20692180
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Increase of the Driving Speed After the Apparatus by Walkaide® Medical Device in Deficits Levator Foot of Central Origin.
- ClinicalTrials.gov ID
- NCT02639689
- Acronym / sponsor ID
- WALKAIDE / CHU PROMOTEUR 2013/12
- Conditions
- Foot Sensory Deficit
- Keywords
- Deficits of foot relievers of central origin, Walkaide
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 24 Dec 2015 (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.
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.
Detailed description
Evaluation of the increase of the driving speed after apparatus by Walkaide® medical device in deficits levator foot of central origin.
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotic and walking with orthotic Walkaide® medical devie after one month of training.
This is a prospective multicenter study, without control group, qualified as a biomedical research.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WALKAIDE | Experimental | Device: WALKAIDEA clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device. Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Passive ankle dorsiflexion of at least 0 ° (strained knee)
- No injection of botulinum toxin in the lower limbs for at months 3 months
- No surgery for at least three months
- Walk 10 meters in less than 60 seconds, without human help, with or without technical assistance
- Score the Functional Ambulation Classification (FAC) ≥ 3
Key exclusion criteria (7 listed)
- Presence of severe cognitive impairment that does not allow the use of the device independently
- History of debilitating disease associated general
- Local embarrassing skin disorder laying the electrodes
- Pacemaker
- Unstable Epilepsy
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 |
|---|---|---|
| WALKAIDEA clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device. Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device. | Device | WALKAIDE |
Primary outcome
Change in walking speed
Time frame: One month
The main objective is the study of changes in walking speed on the 6-minute walk test between the initial walk without orthotics and walking with Walkaide® functionnal electric stimulation orthosis after one month of training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Results publication: PubMed 19846759Stein RB, Everaert DG, Thompson AK, Chong SL, Whittaker M, Robertson J, Kuether G. Long-term therapeutic and orthotic effects of a foot drop stimulator on walking performance in progressive and nonprogressive neurological disorders. Neurorehabil Neural Repair. 2010 Feb;24(2):152-67. doi: 10.1177/1545968309347681. Epub 2009 Oct 21.
- Results publication: PubMed 14654207Detrembleur C, Dierick F, Stoquart G, Chantraine F, Lejeune T. Energy cost, mechanical work, and efficiency of hemiparetic walking. Gait Posture. 2003 Oct;18(2):47-55. doi: 10.1016/s0966-6362(02)00193-5.
- Results publication: PubMed 15153151Kottink AI, Oostendorp LJ, Buurke JH, Nene AV, Hermens HJ, IJzerman MJ. The orthotic effect of functional electrical stimulation on the improvement of walking in stroke patients with a dropped foot: a systematic review. Artif Organs. 2004 Jun;28(6):577-86. doi: 10.1111/j.1525-1594.2004.07310.x.
- Results publication: PubMed 19861590Everaert DG, Thompson AK, Chong SL, Stein RB. Does functional electrical stimulation for foot drop strengthen corticospinal connections? Neurorehabil Neural Repair. 2010 Feb;24(2):168-77. doi: 10.1177/1545968309349939. Epub 2009 Oct 27.
- Results publication: PubMed 20692180Sabut SK, Lenka PK, Kumar R, Mahadevappa M. Effect of functional electrical stimulation on the effort and walking speed, surface electromyography activity, and metabolic responses in stroke subjects. J Electromyogr Kinesiol. 2010 Dec;20(6):1170-7. doi: 10.1016/j.jelekin.2010.07.003. Epub 2010 Aug 6.
- Les CapucinsLink provided by the sponsor.
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.
Isabelle Richard, md-PHD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WALKAIDE in people with Foot Sensory Deficit, run by University Hospital, Angers at 1 site in France.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle Richard Crémieux, Md-PHD (0241351719 ext. 33, Isabelle.richard@univ-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed (time frame: One month). 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 NCT02639689, which also lists 5 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 24 Dec 2015.