StrokeANANTANCT01952522
Effects of a Walking Intervention With Additional Weights on the Unaffected Leg in People After Stroke
A study testing Weighted brace and Non weighted brace in people with Stroke and Hemiparesis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- Weighted brace and Non weighted brace
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2013to 8 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiparesis following ischemic or hemorrhagic infarct of a single hemisphere
- First episode of stroke experienced > 3 months and < 5 years prior to study enrolment
- Functional Ambulation Categories (FAC) score > 3 < 8
- Be able to walk few meters without physical assistance
- Able to understand and follow instructions
Who cannot join
- Following inpatient physical rehabilitation
- Experienced more than 2 falls during 3 months prior inclusion
- Signs of bilateral impairments
- Daily use of a wheelchair to move
- Contra-indications for daily walk
- Currently participating in any clinical trial with a experimental walking intervention
- Severe arthrosis
- Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight).
Read the detailed description
Improve walking ability in people after stroke is a key objective for rehabilitation. Once the rehabilitation period is finished, a reduction of functional and motor abilities is often observed in subjects when they returned home.
This study will examine if loading daily the non paretic leg with additional weights will improve walking abilities. This study will enroll 100 people who had a stroke > three months and < five years and who still experienced difficulties for walking.
Each patient will receive 3 months of intervention targeting their non affected leg. Half of the subjects will have to wear braces with additional weights at the non affected ankle during the day ( > 6 hours), while the other half will wear a similar brace but without weight.
A six minutes walking test will be given before and after the intervention, as well six and twelve months later to measure the effect of these interventions. The investigators hypothesize that people receiving the additional weights to the non paretic leg will show greater improvements in their walk abilities.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Weighted brace, Non weighted brace
- Keywords
- Resistance training, Walking, Weight bearing
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted braceBehavioural
People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
Non weighted braceBehavioural
People will be given a brace with no weight they will have to wear all the day during three months.
| Study group | Role | What they receive |
|---|---|---|
| Weighted brace | Experimental | Not described Receives: Behavioral: Weighted brace |
| non weighted brace | Placebo comparator | Not described Receives: Behavioral: Non weighted brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minutes walking test
Total distance walked in meters (6MWD) within the 6 minutes.
Measured: 3 months after the inclusion
Secondary outcomes (2)
six minutes walking test
Total distance walked in meters (6MWD) within the 6 minutes
Measured: 6 months after the inclusion
six minutes walking test
Total distance walked in meters (6MWD) within the 6 minutes
Measured: 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study start17 May 2013
- Primary completion8 Sep 2016
- Study completion8 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Sainte Anne, Paris, Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe Regnaux, PhD, Study director, French School of Public Health (EHESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952522
- Sponsor's protocol ID
- P110702
- Acronym
- ANANTA
- Status last verified
- Sep 2025
- First submitted
- 3 May 2013
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Rehabilitation Programs to Improve Walking in Community-dwelling People After Stroke
- ClinicalTrials.gov ID
- NCT01952522
- Acronym / sponsor ID
- ANANTA / P110702
- Conditions
- Stroke, Hemiparesis
- Keywords
- Resistance training, Walking, Weight bearing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre Hospitalier Sainte Anne, Paris, Département d'Epidémiologie Clinique, Hôpital Hôtel-Dieu, Paris, URC-CIC Paris Descartes Necker Cochin
- Study start
- 17 May 2013 (actual)
- Primary completion
- 8 Sep 2016 (actual)
- Study completion
- 8 Sep 2016 (actual)
- First posted
- 30 Sep 2013 (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.
This study is designed to determine if adding daily weighted braces on the unaffected ankle may benefit to patient who have returned home compare to a placebo intervention (ankle brace without weight).
Detailed description
Improve walking ability in people after stroke is a key objective for rehabilitation. Once the rehabilitation period is finished, a reduction of functional and motor abilities is often observed in subjects when they returned home.
This study will examine if loading daily the non paretic leg with additional weights will improve walking abilities. This study will enroll 100 people who had a stroke > three months and < five years and who still experienced difficulties for walking.
Each patient will receive 3 months of intervention targeting their non affected leg. Half of the subjects will have to wear braces with additional weights at the non affected ankle during the day ( > 6 hours), while the other half will wear a similar brace but without weight.
A six minutes walking test will be given before and after the intervention, as well six and twelve months later to measure the effect of these interventions. The investigators hypothesize that people receiving the additional weights to the non paretic leg will show greater improvements in their walk abilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted brace | Experimental | Behavioral: Weighted brace |
| non weighted brace | Placebo comparator | Behavioral: Non weighted brace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hemiparesis following ischemic or hemorrhagic infarct of a single hemisphere
- First episode of stroke experienced > 3 months and < 5 years prior to study enrolment
- Functional Ambulation Categories (FAC) score > 3 < 8
- Be able to walk few meters without physical assistance
- Able to understand and follow instructions
Key exclusion criteria (8 listed)
- Following inpatient physical rehabilitation
- Experienced more than 2 falls during 3 months prior inclusion
- Signs of bilateral impairments
- Daily use of a wheelchair to move
- Contra-indications for daily walk
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 |
|---|---|---|
| Weighted bracePeople will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months | Behavioural | Weighted brace |
| Non weighted bracePeople will be given a brace with no weight they will have to wear all the day during three months. | Behavioural | non weighted brace |
Primary outcome
Six minutes walking test
Time frame: 3 months after the inclusion
Total distance walked in meters (6MWD) within the 6 minutes.
2 secondary outcomes
six minutes walking test
Time frame: 6 months after the inclusion
six minutes walking test
Time frame: 12 months after the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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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.
Jean-Philippe Regnaux, PhD study director
French School of Public Health (EHESP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted brace and Non weighted brace in people with Stroke and Hemiparesis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 15 Sep 2025. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Six minutes walking test (time frame: 3 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.