StrokeProHandNCT02878304
Biomarkers for Prediction of Hand Function After Stroke - The ProHand Study
An observational study of Stroke and Hemiparesis, run by Danderyd Hospital at 1 site in Sweden.
Trial summary
The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Hemiparesis
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Dec 2017
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients are recruited at entry to a specialized sub-acute rehabilitation unit after first time stroke
Who may be able to join
- first ever stroke and clinically diagnosed arm paresis
Who cannot join
- incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Danderyd University Hospital
Stockholm, Danderyd, 18288
Jeanette Plantin, PhD stud., 00467969495796, jeanette.plantin@ki.se
About this study
Official title: Recovery of Hand Function After Stroke- a Longitudinal Study Using Novel Methods to Quantify Hand Function and Connectivity in Brain Networks
The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures.
Read the detailed description
Almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. Improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation.
100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. The imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional MRI for structural and functional connectivity analyses, respectively. Clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function.
ProHand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.
- Conditions
- Stroke, Hemiparesis
- Keywords
- Prognosis, Hand function, Rehabilitation, Spasticity, MRI
- Medical subject headings
- Stroke, Paresis, Muscle Spasticity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Assessment for Upper Extremity
Measured: From 4 weeks to 3 and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startMar 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörgen Borg, Professor, Study director, Department of Rehabilitation Medicine, Danderyd University Hospital, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878304
- Sponsor's protocol ID
- PROHAND_001
- Acronym
- ProHand
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 25 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Plantin J, Verneau M, Godbolt AK, Pennati GV, Laurencikas E, Johansson B, Krumlinde-Sundholm L, Baron JC, Borg J, Lindberg PG. Recovery and Prediction of Bimanual Hand Use After Stroke. Neurology. 2021 Aug 17;97(7):e706-e719. doi: 10.1212/WNL.0000000000012366. Epub 2021 Jun 14.
PubMed 34400568Hybbinette H, Ostberg P, Schalling E. Intra- and Interjudge Reliability of the Apraxia of Speech Rating Scale in Early Stroke Patients. J Commun Disord. 2021 Jan-Feb;89:106076. doi: 10.1016/j.jcomdis.2020.106076. Epub 2021 Jan 6.
PubMed 33493822Pennati GV, Plantin J, Carment L, Roca P, Baron JC, Pavlova E, Borg J, Lindberg PG. Recovery and Prediction of Dynamic Precision Grip Force Control After Stroke. Stroke. 2020 Mar;51(3):944-951. doi: 10.1161/STROKEAHA.119.026205. Epub 2020 Jan 7.
PubMed 31906829
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Hand Function After Stroke- a Longitudinal Study Using Novel Methods to Quantify Hand Function and Connectivity in Brain Networks
- ClinicalTrials.gov ID
- NCT02878304
- Acronym / sponsor ID
- ProHand / PROHAND_001
- Conditions
- Stroke, Hemiparesis
- Keywords
- Prognosis, Hand function, Rehabilitation, Spasticity, MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Aug 2016 (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.
The overall aim is to identify key determinants for recovery of hand function after stroke by applying newly developed hand function measures together with MRI measurements of the lesioned cerebral structures.
Detailed description
Almost half of surviving stroke patients are left with impaired function of the hand but individual profiles of weakness, spasticity, sensory and bimanual function vary widely. Improved prediction of recovery after stroke has broad implications for clinical decisions on the type, duration and goals of rehabilitation.
100 consecutive patients with 1st ever stroke and upper limb hemi-paresis will be subject to imaging, at 4 weeks and 6 months, and behavioral assessments at 4 weeks, 3 months and 6 months after stroke. The imaging protocol includes anatomical sequences for lesion mapping, diffusion tensor imaging and resting-state functional MRI for structural and functional connectivity analyses, respectively. Clinical hand function measures will be combined with novel validated methods to quantify spasticity,grip force control, sensory and bimanual function.
ProHand will provide insights into neural mechanisms related to recovery of hand function after stroke and enable enhanced prediction and development of targeted treatment trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are recruited at entry to a specialized sub-acute rehabilitation unit after first time stroke
Key inclusion criteria (1 listed)
- first ever stroke and clinically diagnosed arm paresis
Key exclusion criteria (1 listed)
- incapability to give informed concent and/or understand and comply with instructions, other disorders that may affect hand function (e.g. other neurological conditions, arthritis), cerebellar lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Fugl-Meyer Assessment for Upper Extremity
Time frame: From 4 weeks to 3 and six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Derived from this study: PubMed 34400568Plantin J, Verneau M, Godbolt AK, Pennati GV, Laurencikas E, Johansson B, Krumlinde-Sundholm L, Baron JC, Borg J, Lindberg PG. Recovery and Prediction of Bimanual Hand Use After Stroke. Neurology. 2021 Aug 17;97(7):e706-e719. doi: 10.1212/WNL.0000000000012366. Epub 2021 Jun 14.
- Derived from this study: PubMed 33493822Hybbinette H, Ostberg P, Schalling E. Intra- and Interjudge Reliability of the Apraxia of Speech Rating Scale in Early Stroke Patients. J Commun Disord. 2021 Jan-Feb;89:106076. doi: 10.1016/j.jcomdis.2020.106076. Epub 2021 Jan 6.
- Derived from this study: PubMed 31906829Pennati GV, Plantin J, Carment L, Roca P, Baron JC, Pavlova E, Borg J, Lindberg PG. Recovery and Prediction of Dynamic Precision Grip Force Control After Stroke. Stroke. 2020 Mar;51(3):944-951. doi: 10.1161/STROKEAHA.119.026205. Epub 2020 Jan 7.
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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.
Jörgen Borg, Professor study director
Department of Rehabilitation Medicine, Danderyd University Hospital, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiparesis, run by Danderyd Hospital at 1 site in Sweden.
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 1 inclusion and 1 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 25 Aug 2016. 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 Sweden. 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.
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 Jeanette AM Plantin, PhD student (0046709169232, jeanette.plantin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Assessment for Upper Extremity (time frame: From 4 weeks to 3 and six months). 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 NCT02878304, which also lists 3 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 25 Aug 2016.