|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 November 2021 |
|
Main ID: |
NCT03155399 |
|
Date of registration:
|
15/05/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients
BAT |
|
Scientific title:
|
Proprioceptive Stimulation With Manual Bilateral Rhythmic Exercise in Post-stroke Patients (Stimolazione Propriocettiva Manuale Con Esercizio Ritmico Bilaterale in Pazienti Post Ictus - BAT) |
|
Date of first enrolment:
|
July 2013 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Terminated |
|
URL:
|
https://clinicaltrials.gov/show/NCT03155399 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Michela Agostini, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione Ospedale San Camillo IRCCS |
|
|
Name:
|
Pawel Kiper, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione Ospedale San Camillo IRCCS |
|
|
Name:
|
Andrea Turolla, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione Ospedale San Camillo IRCCS |
|
|
Name:
|
Alfonc Baba, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Fondazione Ospedale San Camillo IRCCS |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. time since stroke up to 6 months,
2. presence of the upper limb plegia (0 point according to the Medical Research Council
scale),
3. passive range of motion (ROM) completely free,
4. absence of primary joint trauma of the wrist, elbow and shoulder,
Exclusion Criteria:
1. increased muscle tone (score higher than 1 point in modified Ashworth scale),
2. apraxia (De Renzi test < 62 points),
3. global sensory aphasia (clinical notes),
4. neglect (clinical notes),
5. cognitive impairments (Mini Mental State Examination test < 24 points) ,
6. severe sensitivity disorders ( < 1 point in items shoulder, elbow, wrist and thumb at
the proprioceptive sensitivity section of the Fugl-Meyer scale),
7. stroke lesion located in the cerebellum (clinical notes).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Hemiparesis
|
|
Stroke
|
|
Intervention(s)
|
|
Other: Conventional neuromotor treatment (CNT).
|
|
Other: Proprioceptive based training (PBT)
|
|
Primary Outcome(s)
|
|
Dynamometer
[Time Frame: Change from baseline of dynamometer at the end of PBT (three weeks thereafter)]
|
|
Medical Research Council scale (MRC)
[Time Frame: Change from baseline of the MRC scale at the end of PBT (three weeks thereafter)]
|
|
Secondary Outcome(s)
|
|
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)]
|
|
Modified Ashworth Scale
[Time Frame: Change from baseline of the Ashworth 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)]
|
|
surface Electromyography (sEMG)
[Time Frame: Change from baseline of the MVC at the end of PBT (three weeks thereafter)]
|
|
Secondary ID(s)
|
|
Protocollo 2012.07 BAT v.1.2
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|