StrokeNCT01936298
Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
A study testing A-ROM Continuous Passive Rehabilitation and P-ROM Continuous Passive Rehabilitation in people with Stroke, run by Chiara Mulé at 1 site in Italy.
Trial summary
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- A-ROM Continuous Passive Rehabilitation and P-ROM Continuous Passive Rehabilitation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Oct 2013
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of acute phase of stroke (less than 12 months post onset),
- first stroke episode,
- no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
- no contracture of the affected wrist or fingers (Modified Ashworth<3),
- no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
- for P-ROM patients, the absence of active hand movements,
- for the A-ROM patients, the presence of active hand movements.
Who cannot join
- unstable medical disorders,
- active Complex Regional Pain Syndrome (CRPS),
- severe spatial neglect,
- aphasia,
- cognitive problems.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
Read the detailed description
We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.
We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.
- Conditions
- Stroke
- Being tested
- A-ROM Continuous Passive Rehabilitation, P-ROM Continuous Passive Rehabilitation
- Keywords
- Hand Edema, Exercise Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-ROM Continuous Passive RehabilitationDevice
Also called Continuous Passive Motion device for hand: Gloreha
Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
P-ROM Continuous Passive RehabilitationDevice
Also called Continuous Passive Motion device for hand: Gloreha
Half an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually).
| Study group | Role | What they receive |
|---|---|---|
| A-ROM Continuous Passive Rehabilitation | Experimental | The group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. Receives: Device: A-ROM Continuous Passive Rehabilitation |
| P-ROM Continuous Passive Rehabilitation | Experimental | The group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. Receives: Device: P-ROM Continuous Passive Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Perimeter edema
Measured: 1 day after the treatment
Secondary outcomes (4)
Change from Baseline of Visual analogue scale (VAS)
Measured: 1 day after the treatment
Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
Measured: 1 day after the treatment
Change from Baseline of Range Of Motion (ROM)
Measured: 1 day after the treatment
Clinical Global Impression (CGI)
Measured: 1 day after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiara Mulé
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chiara Mulé, Habilita, Ospedale di Sarnico
- Investigators
- Chiara Mulé, MD, Principal investigator, Habilita, Ospedale di Sarnico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01936298
- Sponsor's protocol ID
- GLO01
- Status last verified
- Oct 2013
- First submitted
- 2 Sep 2013
- Last updated
- 28 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yamaguchi T, Tanabe S, Muraoka Y, Imai S, Masakado Y, Hase K, Kimura A, Liu M. Effects of integrated volitional control electrical stimulation (IVES) on upper extremity function in chronic stroke. Keio J Med. 2011;60(3):90-5. doi: 10.2302/kjm.60.90.
PubMed 21964036Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245Kim EH, Chang MC, Seo JP, Jang SH, Song JC, Jo HM. The effect of a hand-stretching device during the management of spasticity in chronic hemiparetic stroke patients. Ann Rehabil Med. 2013 Apr;37(2):235-40. doi: 10.5535/arm.2013.37.2.235. Epub 2013 Apr 30.
PubMed 23705119Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
PubMed 6932734Bell A, Muller M. Effects of kinesio tape to reduce hand edema in acute stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):283-8. doi: 10.1310/tsr2003-283.
PubMed 23841976Bialosky JE, George SZ, Bishop MD. How spinal manipulative therapy works: why ask why? J Orthop Sports Phys Ther. 2008 Jun;38(6):293-5. doi: 10.2519/jospt.2008.0118. Epub 2008 May 27. No abstract available.
PubMed 18515964Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
PubMed 15207508Kong KH, Chua KS, Lee J. Symptomatic upper limb spasticity in patients with chronic stroke attending a rehabilitation clinic: frequency, clinical correlates and predictors. J Rehabil Med. 2010 May;42(5):453-7. doi: 10.2340/16501977-0545.
PubMed 20544156Lundstrom E, Smits A, Terent A, Borg J. Time-course and determinants of spasticity during the first six months following first-ever stroke. J Rehabil Med. 2010 Apr;42(4):296-301. doi: 10.2340/16501977-0509.
PubMed 20461330Villafane JH, Valdes K. Combined thumb abduction and index finger extension strength: a comparison of older adults with and without thumb carpometacarpal osteoarthritis. J Manipulative Physiol Ther. 2013 May;36(4):238-44. doi: 10.1016/j.jmpt.2013.05.004. Epub 2013 May 27.
PubMed 23719517Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
PubMed 21856077Chang CW, Kuo LC, Cheng YT, Su FC, Jou IM, Sun YN. Reliable model-based kinematics analysis system for articulated fingers. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:4675-8. doi: 10.1109/IEMBS.2007.4353383.
PubMed 18003049Borboni A, Villafane JH, Mulle C, Valdes K, Faglia R, Taveggia G, Negrini S. Robot-Assisted Rehabilitation of Hand Paralysis After Stroke Reduces Wrist Edema and Pain: A Prospective Clinical Trial. J Manipulative Physiol Ther. 2017 Jan;40(1):21-30. doi: 10.1016/j.jmpt.2016.10.003. Epub 2016 Nov 12.
PubMed 27847124
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Rehabilitation of Hand by Paralysis of the Upper Limb After Stroke
- ClinicalTrials.gov ID
- NCT01936298
- Acronym / sponsor ID
- GLO01
- Conditions
- Stroke
- Keywords
- Hand Edema, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Chiara MuléUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 6 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.
The investigators evaluate the effectiveness of the application of continuous passive motion device for hand rehabilitation in two classes of patients: with a residual active motion and without a residual active motion.
Detailed description
We will conduct a double blind clinical trial. A sample size calculation were performed to determine the necessary number of subjects needed for this study and was based upon the results of a previous pilot study. All patients had functional impairments of their upper extremities after the stroke.
We hypothesized that the hand-rehabilitation oriented with robotics assistance, would improve edema by paralysis of the upper limb even in patient without sensory pathway recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-ROM Continuous Passive Rehabilitation | Experimental | Device: A-ROM Continuous Passive RehabilitationThe group of patients with Active Range Of Motion (A-ROM) is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. |
| P-ROM Continuous Passive Rehabilitation | Experimental | Device: P-ROM Continuous Passive RehabilitationThe group of patients with Passive Range Of Motion (P-ROM), i.e. without active movements of the hand at the baseline, is subjected to two session per day in the morning and in the afternoon over a period of two weeks (5 days per week). Each session is composed by 30 min of continuous passive motion rehabilitation and 60 min of physical and occupational therapy. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- a history of acute phase of stroke (less than 12 months post onset),
- first stroke episode,
- no history of peripheral nerve injury or musculoskeletal disease in the affected upper extremity,
- no contracture of the affected wrist or fingers (Modified Ashworth<3),
- no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months before the start of this study,
Key exclusion criteria (5 listed)
- unstable medical disorders,
- active Complex Regional Pain Syndrome (CRPS),
- severe spatial neglect,
- aphasia,
- cognitive problems.
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 |
|---|---|---|
| A-ROM Continuous Passive RehabilitationAlso: Continuous Passive Motion device for hand: GlorehaHalf an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually). | Device | A-ROM Continuous Passive Rehabilitation |
| P-ROM Continuous Passive RehabilitationAlso: Continuous Passive Motion device for hand: GlorehaHalf an hour of treatment during the morning with the "sequential" program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the "synchronous" program (II-III-IV-V finger are mobilized simultaneously, the thumb individually). | Device | P-ROM Continuous Passive Rehabilitation |
Primary outcome
Change from Baseline of Perimeter edema
Time frame: 1 day after the treatment
4 secondary outcomes
Change from Baseline of Visual analogue scale (VAS)
Time frame: 1 day after the treatment
Change from Baseline of Modified Ashworth Scale for Grading Spasticity (MAS)
Time frame: 1 day after the treatment
Change from Baseline of Range Of Motion (ROM)
Time frame: 1 day after the treatment
Clinical Global Impression (CGI)
Time frame: 1 day after the treatment
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 28 Oct 2013.
- Background: PubMed 21964036Yamaguchi T, Tanabe S, Muraoka Y, Imai S, Masakado Y, Hase K, Kimura A, Liu M. Effects of integrated volitional control electrical stimulation (IVES) on upper extremity function in chronic stroke. Keio J Med. 2011;60(3):90-5. doi: 10.2302/kjm.60.90.
- Background: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
- Background: PubMed 23705119Kim EH, Chang MC, Seo JP, Jang SH, Song JC, Jo HM. The effect of a hand-stretching device during the management of spasticity in chronic hemiparetic stroke patients. Ann Rehabil Med. 2013 Apr;37(2):235-40. doi: 10.5535/arm.2013.37.2.235. Epub 2013 Apr 30.
- Background: PubMed 6932734Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.
- Background: PubMed 23841976Bell A, Muller M. Effects of kinesio tape to reduce hand edema in acute stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):283-8. doi: 10.1310/tsr2003-283.
- Background: PubMed 18515964Bialosky JE, George SZ, Bishop MD. How spinal manipulative therapy works: why ask why? J Orthop Sports Phys Ther. 2008 Jun;38(6):293-5. doi: 10.2519/jospt.2008.0118. Epub 2008 May 27. No abstract available.
- Background: PubMed 15207508Salaffi F, Stancati A, Silvestri CA, Ciapetti A, Grassi W. Minimal clinically important changes in chronic musculoskeletal pain intensity measured on a numerical rating scale. Eur J Pain. 2004 Aug;8(4):283-91. doi: 10.1016/j.ejpain.2003.09.004.
- Background: PubMed 20544156Kong KH, Chua KS, Lee J. Symptomatic upper limb spasticity in patients with chronic stroke attending a rehabilitation clinic: frequency, clinical correlates and predictors. J Rehabil Med. 2010 May;42(5):453-7. doi: 10.2340/16501977-0545.
- Background: PubMed 20461330Lundstrom E, Smits A, Terent A, Borg J. Time-course and determinants of spasticity during the first six months following first-ever stroke. J Rehabil Med. 2010 Apr;42(4):296-301. doi: 10.2340/16501977-0509.
- Background: PubMed 23719517Villafane JH, Valdes K. Combined thumb abduction and index finger extension strength: a comparison of older adults with and without thumb carpometacarpal osteoarthritis. J Manipulative Physiol Ther. 2013 May;36(4):238-44. doi: 10.1016/j.jmpt.2013.05.004. Epub 2013 May 27.
- Background: PubMed 21856077Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
- Background: PubMed 18003049Chang CW, Kuo LC, Cheng YT, Su FC, Jou IM, Sun YN. Reliable model-based kinematics analysis system for articulated fingers. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:4675-8. doi: 10.1109/IEMBS.2007.4353383.
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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.
Chiara Mulé, MD principal investigator
Habilita, Ospedale di Sarnico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-ROM Continuous Passive Rehabilitation and P-ROM Continuous Passive Rehabilitation in people with Stroke, run by Chiara Mulé 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 7 inclusion and 5 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 28 Oct 2013. 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 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?
Change from Baseline of Perimeter edema (time frame: 1 day after the treatment). 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 NCT01936298, which also lists 13 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 28 Oct 2013.