StrokeBATNCT03155399
Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients
A study testing Proprioceptive based training (PBT) and Conventional neuromotor treatment (CNT). in people with Stroke and Hemiparesis, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the effect of the repetitive proprioceptive bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke patients. 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?
- Proprioceptive based training (PBT) and Conventional neuromotor treatment (CNT).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Dec 2018
- 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
- time since stroke up to 6 months,
- presence of the upper limb plegia (0 point according to the Medical Research Council scale),
- passive range of motion (ROM) completely free,
- absence of primary joint trauma of the wrist, elbow and shoulder,
Who cannot join
- increased muscle tone (score higher than 1 point in modified Ashworth scale),
- apraxia (De Renzi test < 62 points),
- global sensory aphasia (clinical notes),
- neglect (clinical notes),
- cognitive impairments (Mini Mental State Examination test < 24 points) ,
- severe sensitivity disorders ( < 1 point in items shoulder, elbow, wrist and thumb at the proprioceptive sensitivity section of the Fugl-Meyer scale),
- stroke lesion located in the cerebellum (clinical notes).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients (Stimolazione Propriocettiva Manuale Con Esercizio Ritmico Bilaterale in Pazienti Post Ictus - BAT)
The purpose of this study is to evaluate the effect of the repetitive proprioceptive bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke patients.
Read the detailed description
The central nervous system (CNS) has plastic properties allowing its adaptation through development. These properties are still maintained in the adult age and potentially activated in case of brain lesion. In the present study authors hypothesized that a significant recovery of voluntary muscle contraction in post stroke patients experiencing severe upper limb paresis can be obtained, when proprioceptive based stimulations are provided. The proprioceptive based training (PBT) aims to stimulate the emergence of voluntary contraction and to foster motor recovery. It is based on motor learning principles, such as the repetition of tasks with concurrent use of feedbacks. The proposed concept is based on the concurrent repetitions of movements performed with the non-affected limb and with the affected one, passively mobilized by physiotherapist in charge of guaranteeing the optimal kinematic execution.
- Conditions
- Stroke, Hemiparesis
- Being tested
- Proprioceptive based training (PBT), Conventional neuromotor treatment (CNT).
- Keywords
- Stroke, Neurorehabilitation, Proprioceptive Training, Bilateral Arm Training, Intracortical Inhibition
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive based training (PBT)Other
During the PBT patient will stay in supine position with the upper limbs positioned in symmetric posture. He/She will be asked to move both limbs with the same frequency performing bilateral flexion-extension of one of the upper limb districts according to the available free ROM of the target joint. The movement execution of the affected arm will be supported by the physiotherapist performing passive movement at the same rhythm, as the one executed with the unaffected side. Patient will be asked to focus the attention on the movement performed against gravity, which will be reinforced by a verbal command. Afterwards, the physiotherapist will fully support movement execution coherently with the patient's movement initialization. The active movement performed voluntarily by the patient with unaffected limb will be considered as the reference movement, that the physiotherapist has to emulate passively, by synchronization of passive movement executed in phase with the affected side.
Conventional neuromotor treatment (CNT).Other
The patients randomized to the CNT group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity.
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive based training (PBT) | Experimental | The treatment will last one hour and will be divided as follows: 2 proprioceptive based stimulation sessions per 3 minutes for each movement, with a rest of 2 minutes between each session. Every patient will receive 15 treatments, 5 days a week, for 3 weeks. Receives: Other: Proprioceptive based training (PBT) |
| Conventional neuromotor treatment (CNT) | Other | The CNT group will be treated for one hour daily by means of a CNT programme. The treatment will last 3 weeks. Receives: Other: Conventional neuromotor treatment (CNT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Research Council scale (MRC)
Applied at the beginning and at the end of treatment (after 15 sessions). The following muscles will be considered: deltoid, biceps brachii, triceps brachii, flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, flexor digitorum and extensor digitorum.
Measured: Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)
Dynamometer
Applied at the beginning and at the end of treatment (after 15 sessions)
Measured: Change from baseline of dynamometer at the end of PBT (three weeks thereafter)
Secondary outcomes (4)
Fugl-Meyer Upper Extremity scale (FM UE)
Applied at the beginning and at the end of treatment (after 15 sessions).
Measured: Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)
Functional Independence Measure scale (FIM)
Applied at the beginning and at the end of treatment (after 15 sessions)
Measured: Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)
Modified Ashworth Scale
Applied at the beginning and at the end of treatment (after 15 sessions).
Measured: Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)
surface Electromyography (sEMG)
Applied at the beginning and at the end of treatment (after 15 sessions) and aiming to record the maximal voluntary contraction (MVC). sEMG signal will be recorded online during the tasks in each modality with bipolar electrodes from the following muscles; long head of biceps brachii, short head of biceps brachii, long head of triceps brachii and lateral head of triceps brachii.
Measured: Change from baseline of the MVC at the end of PBT (three weeks thereafter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startJul 2013
- Primary completionSep 2018
- Study completionDec 2018
Why it stopped: PI transferred to another Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Camillo, Venezia, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Kiper, IRCCS San Camillo, Venezia, Italy
- Investigators
- Pawel Kiper, PhD, Principal investigator, Fondazione Ospedale San Camillo IRCCSAndrea Turolla, PhD, Study director, Fondazione Ospedale San Camillo IRCCSMichela Agostini, MSc, Study chair, Fondazione Ospedale San Camillo IRCCSAlfonc Baba, MSc, Study chair, Fondazione Ospedale San Camillo IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155399
- Sponsor's protocol ID
- Protocollo 2012.07 BAT v.1.2
- Acronym
- BAT
- Status last verified
- Nov 2021
- First submitted
- 15 May 2017
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kiper P, Szczudlik A, Venneri A, Stozek J, Luque-Moreno C, Opara J, Baba A, Agostini M, Turolla A. Computational models and motor learning paradigms: Could they provide insights for neuroplasticity after stroke? An overview. J Neurol Sci. 2016 Oct 15;369:141-148. doi: 10.1016/j.jns.2016.08.019. Epub 2016 Aug 11.
PubMed 27653881Kiper P, Baba A, Agostini M, Turolla A. Proprioceptive Based Training for stroke recovery. Proposal of new treatment modality for rehabilitation of upper limb in neurological diseases. Arch Physiother. 2015 Aug 3;5:6. doi: 10.1186/s40945-015-0007-8. eCollection 2015.
PubMed 29340175
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients (Stimolazione Propriocettiva Manuale Con Esercizio Ritmico Bilaterale in Pazienti Post Ictus - BAT)
- ClinicalTrials.gov ID
- NCT03155399
- Acronym / sponsor ID
- BAT / Protocollo 2012.07 BAT v.1.2
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Neurorehabilitation, Proprioceptive Training, Bilateral Arm Training, Intracortical Inhibition
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI transferred to another Institution
- Enrolment
- 34 participants (actual)
- Lead sponsor
- IRCCS San Camillo, Venezia, ItalyUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 16 May 2017 (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.
The purpose of this study is to evaluate the effect of the repetitive proprioceptive bilateral stimulation for the early recovery of the voluntary muscle contraction in stroke patients.
Detailed description
The central nervous system (CNS) has plastic properties allowing its adaptation through development. These properties are still maintained in the adult age and potentially activated in case of brain lesion. In the present study authors hypothesized that a significant recovery of voluntary muscle contraction in post stroke patients experiencing severe upper limb paresis can be obtained, when proprioceptive based stimulations are provided. The proprioceptive based training (PBT) aims to stimulate the emergence of voluntary contraction and to foster motor recovery. It is based on motor learning principles, such as the repetition of tasks with concurrent use of feedbacks. The proposed concept is based on the concurrent repetitions of movements performed with the non-affected limb and with the affected one, passively mobilized by physiotherapist in charge of guaranteeing the optimal kinematic execution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive based training (PBT) | Experimental | Other: Proprioceptive based training (PBT)The treatment will last one hour and will be divided as follows: 2 proprioceptive based stimulation sessions per 3 minutes for each movement, with a rest of 2 minutes between each session. Every patient will receive 15 treatments, 5 days a week, for 3 weeks. |
| Conventional neuromotor treatment (CNT) | Other | Other: Conventional neuromotor treatment (CNT).The CNT group will be treated for one hour daily by means of a CNT programme. The treatment will last 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- time since stroke up to 6 months,
- presence of the upper limb plegia (0 point according to the Medical Research Council scale),
- passive range of motion (ROM) completely free,
- absence of primary joint trauma of the wrist, elbow and shoulder,
Key exclusion criteria (7 listed)
- increased muscle tone (score higher than 1 point in modified Ashworth scale),
- apraxia (De Renzi test < 62 points),
- global sensory aphasia (clinical notes),
- neglect (clinical notes),
- cognitive impairments (Mini Mental State Examination test < 24 points) ,
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 |
|---|---|---|
| Proprioceptive based training (PBT)During the PBT patient will stay in supine position with the upper limbs positioned in symmetric posture. He/She will be asked to move both limbs with the same frequency performing bilateral flexion-extension of one of the upper limb districts according to the available free ROM of the target joint. The movement execution of the affected arm will be supported by the physiotherapist performing passive movement at the same rhythm, as the one executed with the unaffected side. Patient will be asked to focus the attention on the movement performed against gravity, which will be reinforced by a verbal command. Afterwards, the physiotherapist will fully support movement execution coherently with the patient's movement initialization. The active movement performed voluntarily by the patient with unaffected limb will be considered as the reference movement, that the physiotherapist has to emulate passively, by synchronization of passive movement executed in phase with the affected side. | Other | Proprioceptive based training (PBT) |
| Conventional neuromotor treatment (CNT).The patients randomized to the CNT group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity. | Other | Conventional neuromotor treatment (CNT) |
Primary outcome
Medical Research Council scale (MRC)
Time frame: Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions). The following muscles will be considered: deltoid, biceps brachii, triceps brachii, flexor carpi radialis, flexor carpi ulnaris, extensor carpi radialis, extensor carpi ulnaris, flexor digitorum and extensor digitorum.
Dynamometer
Time frame: Change from baseline of dynamometer at the end of PBT (three weeks thereafter)
Applied at the beginning and at the end of treatment (after 15 sessions)
4 secondary outcomes
Fugl-Meyer Upper Extremity scale (FM UE)
Time frame: Change from baseline of the FM UE scale at the end of PBT (three weeks thereafter)
Functional Independence Measure scale (FIM)
Time frame: Change from baseline of the FIM scale at the end of PBT (three weeks thereafter)
Modified Ashworth Scale
Time frame: Change from baseline of the Ashworth scale at the end of PBT (three weeks thereafter)
surface Electromyography (sEMG)
Time frame: Change from baseline of the MVC at the end of PBT (three weeks thereafter)
Results and safety
The study was stopped early (reason given: PI transferred to another Institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 27653881Kiper P, Szczudlik A, Venneri A, Stozek J, Luque-Moreno C, Opara J, Baba A, Agostini M, Turolla A. Computational models and motor learning paradigms: Could they provide insights for neuroplasticity after stroke? An overview. J Neurol Sci. 2016 Oct 15;369:141-148. doi: 10.1016/j.jns.2016.08.019. Epub 2016 Aug 11.
- Results publication: PubMed 29340175Kiper P, Baba A, Agostini M, Turolla A. Proprioceptive Based Training for stroke recovery. Proposal of new treatment modality for rehabilitation of upper limb in neurological diseases. Arch Physiother. 2015 Aug 3;5:6. doi: 10.1186/s40945-015-0007-8. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
Pawel Kiper, PhD principal investigator
Fondazione Ospedale San Camillo IRCCS
Andrea Turolla, PhD study director
Fondazione Ospedale San Camillo IRCCS
Michela Agostini, MSc study chair
Fondazione Ospedale San Camillo IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive based training (PBT) and Conventional neuromotor treatment (CNT). in people with Stroke and Hemiparesis, run by IRCCS San Camillo, Venezia, Italy at 1 site in Italy.
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 4 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: stopped early, as of the sponsor's last update on 11 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 Italy. 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?
The study was stopped early (reason given: PI transferred to another Institution). Results are not available in the source record.
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?
Medical Research Council scale (MRC) (time frame: Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)). The study lists 2 primary outcomes in all. 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 NCT03155399, which also lists 2 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 11 Nov 2021.