StrokeEarly Phase 1NCT04339803
Dose-Finding of Lower Limb Mirror Therapy After Stroke.
A Early Phase 1 study testing rehabilitation intervention in people with Stroke, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This study will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. The design is a 3+3 rule based, dose- finding study. Each cohort will consist of three participants. The first cohort will be assigned to do a dose of 15 minutes each day for two weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- rehabilitation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Apr 2019to 9 Aug 2021
- Phase
- Early Phase 1
- 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
- Participants have had a stroke for six weeks or more before recruitment to this study, and are discharged from NHS statutory stroke rehabilitation.
- Participants will be at least 18 years of age
- Able to produce some voluntary contraction of paretic ankle ( motricity index between 9 and 19).
- Ability to understand and follow simple verbal instructions (one-stage commands), i.e. sufficient communication, orientation, and memory to participate in mirror therapy ankle exercise.
- Participants will have had no lower limb injury in the last six months and were able to walk independently indoors before the index stroke.
Who cannot join
- Foot or ankle contracture that prevents 50% of the passive range of motion.
- Any condition that can be exaggerated by performing the therapy.
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. The design is a 3+3 rule based, dose- finding study. Each cohort will consist of three participants. The first cohort will be assigned to do a dose of 15 minutes each day for two weeks. The second and subsequent cohorts will exercise at target dose set accordance to the nine preset rules and the modified Fibonacci sequence (mFBS).The study will continue until the stopping rule is triggered. The last dose tested will be identified as the maximum tolerable dose per day.
Read the detailed description
Procedure:a 3+3 rule-based, dose-escalation design (Colucci et al,2017). recruitment process: the study will begin with a cohort of three participants (n=3). Each of the subsequent cohorts will also be of three participants. The start dose will be set at 15 minutes (cohort one). Participants will do ankle dorsiflexion exercise at the set dose with the mirror for two weeks. The second and subsequent cohorts will exercise at dose set in accordance to the nine preset rules and the modified Fibonacci sequence (mFBS) .
Sample size: The target sample size is not usually predefined for a dose-finding study. The final sample size will be determined by the response of consecutive cohorts to the set dose. Usually, in pharmaceutical dose-finding studies, the sample size lies between 12 and 40.
Data analysis : The data for each cohort will be analysed using descriptive statistics. No significance testing is involved.
- Conditions
- Stroke
- Being tested
- rehabilitation intervention
- Keywords
- Mirror therapy, Rehabilitation, Lower limb, Motor recovery
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation interventionOther
we use lower limb mirror therapy after stroke for two weeks
| Study group | Role | What they receive |
|---|---|---|
| mirror therapy | Experimental | lower limb mirror therapy using ankle exercise Receives: Other: rehabilitation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Motricity Index
Measured: Baseline, 2 weeks.
Secondary outcomes (3)
Changes in the Symmetry
in Tibialis anterior muscle activation between the more and less paretic leg
Measured: Baseline, 2 weeks
Changes in the Neural excitability
at the spinal level using peripheral nerve stimulation-H reflex
Measured: Baseline, 2 weeks
changes in the Transcranial magnetic stimulation (TMS)
Corticospinal tract excitability
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start23 Apr 2019
- Primary completion9 Aug 2021
- Study completion9 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valerie Pomeroy, Professor, Study director, School of Health Sciences, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339803
- Sponsor's protocol ID
- 255913
- Status last verified
- Nov 2021
- First submitted
- 23 Mar 2020
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data only will be shared with the research team
Publications
Bajuaifer S, Grey MJ, Hancock NJ, Chandler E, Pomeroy VM. Maximum tolerable daily dose of mirror movement therapy ankle exercises after stroke: an early phase dose screening study. Physiotherapy. 2024 Mar;122:30-39. doi: 10.1016/j.physio.2023.10.007. Epub 2023 Nov 4.
PubMed 38237263
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Finding of Lower Limb Mirror Therapy After Stroke.
- ClinicalTrials.gov ID
- NCT04339803
- Acronym / sponsor ID
- 255913
- Conditions
- Stroke
- Keywords
- Mirror therapy, Rehabilitation, Lower limb, Motor recovery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 9 Aug 2021 (actual)
- First posted
- 9 Apr 2020 (actual)
- 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 will investigate the maximum dose per day of using mirror therapy for ankle exercise after stroke. The design is a 3+3 rule based, dose- finding study. Each cohort will consist of three participants. The first cohort will be assigned to do a dose of 15 minutes each day for two weeks. The second and subsequent cohorts will exercise at target dose set accordance to the nine preset rules and the modified Fibonacci sequence (mFBS).The study will continue until the stopping rule is triggered. The last dose tested will be identified as the maximum tolerable dose per day.
Detailed description
Procedure:a 3+3 rule-based, dose-escalation design (Colucci et al,2017). recruitment process: the study will begin with a cohort of three participants (n=3). Each of the subsequent cohorts will also be of three participants. The start dose will be set at 15 minutes (cohort one). Participants will do ankle dorsiflexion exercise at the set dose with the mirror for two weeks. The second and subsequent cohorts will exercise at dose set in accordance to the nine preset rules and the modified Fibonacci sequence (mFBS) .
Sample size: The target sample size is not usually predefined for a dose-finding study. The final sample size will be determined by the response of consecutive cohorts to the set dose. Usually, in pharmaceutical dose-finding studies, the sample size lies between 12 and 40.
Data analysis : The data for each cohort will be analysed using descriptive statistics. No significance testing is involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mirror therapy | Experimental | Other: rehabilitation interventionlower limb mirror therapy using ankle exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants have had a stroke for six weeks or more before recruitment to this study, and are discharged from NHS statutory stroke rehabilitation.
- Participants will be at least 18 years of age
- Able to produce some voluntary contraction of paretic ankle ( motricity index between 9 and 19).
- Ability to understand and follow simple verbal instructions (one-stage commands), i.e. sufficient communication, orientation, and memory to participate in mirror therapy ankle exercise.
- Participants will have had no lower limb injury in the last six months and were able to walk independently indoors before the index stroke.
Key exclusion criteria (2 listed)
- Foot or ankle contracture that prevents 50% of the passive range of motion.
- Any condition that can be exaggerated by performing the therapy.
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 |
|---|---|---|
| rehabilitation interventionwe use lower limb mirror therapy after stroke for two weeks | Other | mirror therapy |
Primary outcome
Changes in the Motricity Index
Time frame: Baseline, 2 weeks.
3 secondary outcomes
Changes in the Symmetry
Time frame: Baseline, 2 weeks
Changes in the Neural excitability
Time frame: Baseline, 2 weeks
changes in the Transcranial magnetic stimulation (TMS)
Time frame: Baseline, 2 weeks
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 8 Nov 2021.
- Derived from this study: PubMed 38237263Bajuaifer S, Grey MJ, Hancock NJ, Chandler E, Pomeroy VM. Maximum tolerable daily dose of mirror movement therapy ankle exercises after stroke: an early phase dose screening study. Physiotherapy. 2024 Mar;122:30-39. doi: 10.1016/j.physio.2023.10.007. Epub 2023 Nov 4.
- Individual participant dataSharing planned: No. Participant data only will be shared with the research team
Related trials for Stroke
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The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
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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.
Valerie Pomeroy, Professor study director
School of Health Sciences, University of East Anglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing rehabilitation intervention in people with Stroke, run by University of East Anglia at 1 site in United Kingdom.
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 2 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 8 Nov 2021. 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 United Kingdom. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in the Motricity Index (time frame: Baseline, 2 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 NCT04339803, which also lists 1 linked publication.
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 8 Nov 2021.