Cerebral PalsyNCT03490591
Robot-assisted Hand Rehabilitation for Children With Cerebral Palsy: a Pilot Study
A study testing Robot-assisted hand rehabilitation in people with Cerebral Palsy, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robot-assisted hand rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Apr 2018to 31 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with cerebral palsy(CP) or stroke
- Age younger than 18 and older than 6 years old
- Could follow 2 step order instruction
- No Botulinum injection during the recent 6 month and the experiment period
- Chronicity > 1 years and stable medicine condition
- Could sit steady after the position
Who cannot join
- Individuals with other medical symptoms that can affect movement
- Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei Medical University
Taipei
About this study
Official title: The Effects on Hand Function With Robot-assisted Rehabilitation for Children With Cerebral Palsy: a Pilot Study
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).
Materials and Methods: Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), Grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.
Read the detailed description
Hand function is the most important for ADL and learning ability. Many cerebral palsy(CP) suffered problems with the gross motor dysfunction and hand function disability. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg, school). Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility for cerebral palsy(CP).
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).
Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.
- Conditions
- Cerebral Palsy
- Being tested
- Robot-assisted hand rehabilitation
- Keywords
- Cerebral Palsy, Robotic rehabilitation, Hand function, Activities of Daily Living
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted hand rehabilitationBehavioural
Robot-assisted hand rehabilitation: 20 minute of warm-up exercise and 40 minute of robot-assisted hand exercise intervention. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task, robot-assisted task, and game task.
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted intervention | Experimental | In the Robotic-assisted intervention :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week) Receives: Behavioral: Robot-assisted hand rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment:Upper Limb section
The Fugl-Meyer motor assessments for the upper limb section(scores from 0 to 66 points)that evaluates reflexes, volitional movements and rapid alternating movements. The higher values represent a better outcome.
Measured: Change from baseline to 6 weeks, follow up at one month
Secondary outcomes (4)
Box and block test
The Box and Block Test (BBT) measures unilateral gross manual dexterity. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity.
Measured: Change from baseline to 6 weeks, follow up at one month
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi
Surface electromyography root mean square from brachioradialis and extensor carpi was normalized to the maximal voluntary contraction recording. The higher muscle activation during the task indicate the more efficacy to grasp or release the block.
Measured: Change from baseline to 6 weeks, follow up at one month
Jamar Handgrip Dynamometer
The Jamar hydraulic handgrip dynamometer for measuring the maximum isometric strength of the hand and forearm muscles. The mean score among three trials of each instrument was recorded for data calculations. The higher scores presents the better hand grip strength.
Measured: Change from baseline to 6 weeks, follow up at one month
ABILHAND-Kids questionnaire
A measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved. The parent is asked to rate his/her perception on the response scale as "Impossible", "Difficult" or "Easy" (0 = "Impossible", 1 = "Difficult" or 2 = "Easy"). The activities not attempted by the child within the last 3 months are not scored and are entered as not applicable. The total score based on 21 activities is then converted into a linear measure of manual ability (logits). This test was specifically developed for children with CP using the Rasch measurement model and showed a good reliability and reproducibility over time.
Measured: Change from baseline to 6 weeks, follow up at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start15 Apr 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jui chi Lin, master, Study chair, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490591
- Sponsor's protocol ID
- TMU-JIRB N201711070
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
PubMed 16108461Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.
PubMed 24958005Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032.
PubMed 18929198Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
PubMed 24366991Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N. Effects of contralesional robot-assisted hand training in patients with unilateral spatial neglect following stroke: a case series study. J Neuroeng Rehabil. 2014 Dec 5;11:160. doi: 10.1186/1743-0003-11-160.
PubMed 25476507Sgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015
Fasoli SE, Fragala-Pinkham M, Hughes R, Hogan N, Krebs HI, Stein J. Upper limb robotic therapy for children with hemiplegia. Am J Phys Med Rehabil. 2008 Nov;87(11):929-36. doi: 10.1097/PHM.0b013e31818a6aa4.
PubMed 18936558Ming-Juei Chang (2017).Prevalence, healthcare and rehabilitation services utilization in individuals with cerebral palsy.Taiwan Master Master's Thesis
Levitt, S. (2013). Treatment of cerebral palsy and motor delay. John Wiley & Sons.
Ching-Yi Chen,Ching-Chun Li,Jiunn-Horng Kang(2013). Medical Utilization among Patients with Cerebral Palsy, Taiwan Journal of Physical Medicine and Rehabilitation41(4), 225-234.
McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
PubMed 1463061Asher AV. Handwriting instruction in elementary schools. Am J Occup Ther. 2006 Jul-Aug;60(4):461-71. doi: 10.5014/ajot.60.4.461.
PubMed 16915877Henderson, A., & Pehoski, C. (Eds.). (2006). Hand function in the child: Foundations for remediation. Elsevier Health Sciences.
Hsieh-Chun Hsieh(2010). Effects of Parent-Child Toy-Playing Activities on the Motor Development of Children with Cerebral Palsy. Ulletin of special education, 35(2), 81-101.
Huang, C. W. (2016). Effectiveness of unilateral versus bilateral intensive training in children with cerebral palsy: a randomized controlled study. Taiwan University Occupational Therapy Research Institute Thesis, 1-82.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Hand Function With Robot-assisted Rehabilitation for Children With Cerebral Palsy: a Pilot Study
- ClinicalTrials.gov ID
- NCT03490591
- Acronym / sponsor ID
- TMU-JIRB N201711070
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Robotic rehabilitation, Hand function, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 6 Apr 2018 (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.
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).
Materials and Methods: Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), Grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.
Detailed description
Hand function is the most important for ADL and learning ability. Many cerebral palsy(CP) suffered problems with the gross motor dysfunction and hand function disability. An inability to use the upper extremity in daily life can lead to loss of independence with ADLs and of important occupations (eg, school). Robotic therapy can deliver larger amounts of upper extremity movement practice for these individuals. Although the Robotic therapy appears to provide some benefit for upper extremity motor abilities and participation but is of uncertain utility for cerebral palsy(CP).
Objective: To investigate the effects of robot-assisted hand rehabilitation with a Gloreha device on hand function and the participation of ADL for children with cerebral palsy(CP).
Five children with CP aged 6 to 18 years were recruited and received 12times of robot-assisted hand rehabilitation for 6 weeks of treatment (Sixty minutes a time, twice a week). The performance was assessed by a assessor for three times (pre-test, post-test, follow up at one month). The outcome measures Fugl-Meyer Assessment-Upper Limb section(FMA-UE),Box and block test(BBT), Maximal voluntary contraction(MVC) of extensor digitorum communis(EDC), Flexor digitorum(FD), grasp strength, \& ABILHAND-Kids for ADL ability. Collected data will be analyzed with ANOVA test by SPSS version 20.0, and alpha level was set at .05. Our hypothesis are robot-assisted hand rehabilitation with a Gloreha device has positive effects on hand function and the participation of ADL for children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted intervention | Experimental | Behavioral: Robot-assisted hand rehabilitationIn the Robotic-assisted intervention :12 training sessions of Robot-assisted hand rehabilitation(60 minutes a time, 2 times a week) |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children with cerebral palsy(CP) or stroke
- Age younger than 18 and older than 6 years old
- Could follow 2 step order instruction
- No Botulinum injection during the recent 6 month and the experiment period
- Chronicity > 1 years and stable medicine condition
Key exclusion criteria (2 listed)
- Individuals with other medical symptoms that can affect movement
- Individuals with visual or auditory impairment who couldn't see or hear the feedback from the device clearly
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 |
|---|---|---|
| Robot-assisted hand rehabilitationRobot-assisted hand rehabilitation: 20 minute of warm-up exercise and 40 minute of robot-assisted hand exercise intervention. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task, robot-assisted task, and game task. | Behavioural | Robotic-assisted intervention |
Primary outcome
Fugl-Meyer Assessment:Upper Limb section
Time frame: Change from baseline to 6 weeks, follow up at one month
The Fugl-Meyer motor assessments for the upper limb section(scores from 0 to 66 points)that evaluates reflexes, volitional movements and rapid alternating movements. The higher values represent a better outcome.
4 secondary outcomes
Box and block test
Time frame: Change from baseline to 6 weeks, follow up at one month
EMG: record maximal voluntary contraction(MVC) of brachioradialis, extensor carpi
Time frame: Change from baseline to 6 weeks, follow up at one month
Jamar Handgrip Dynamometer
Time frame: Change from baseline to 6 weeks, follow up at one month
ABILHAND-Kids questionnaire
Time frame: Change from baseline to 6 weeks, follow up at one month
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 12 Jul 2019.
- Background: PubMed 16108461Bax M, Goldstein M, Rosenbaum P, Leviton A, Paneth N, Dan B, Jacobsson B, Damiano D; Executive Committee for the Definition of Cerebral Palsy. Proposed definition and classification of cerebral palsy, April 2005. Dev Med Child Neurol. 2005 Aug;47(8):571-6. doi: 10.1017/s001216220500112x.
- Background: PubMed 24958005Novak I. Evidence-based diagnosis, health care, and rehabilitation for children with cerebral palsy. J Child Neurol. 2014 Aug;29(8):1141-56. doi: 10.1177/0883073814535503. Epub 2014 Jun 22.
- Background: PubMed 18929198Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032.
- Background: PubMed 24366991Sakzewski L, Ziviani J, Boyd RN. Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics. 2014 Jan;133(1):e175-204. doi: 10.1542/peds.2013-0675. Epub 2013 Dec 23.
- Background: PubMed 25476507Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N. Effects of contralesional robot-assisted hand training in patients with unilateral spatial neglect following stroke: a case series study. J Neuroeng Rehabil. 2014 Dec 5;11:160. doi: 10.1186/1743-0003-11-160.
- BackgroundSgaggio, E., Joint and functional benefits of a robotic glove for post-stroke patients. publication pending, 2015
- Background: PubMed 18936558Fasoli SE, Fragala-Pinkham M, Hughes R, Hogan N, Krebs HI, Stein J. Upper limb robotic therapy for children with hemiplegia. Am J Phys Med Rehabil. 2008 Nov;87(11):929-36. doi: 10.1097/PHM.0b013e31818a6aa4.
- BackgroundMing-Juei Chang (2017).Prevalence, healthcare and rehabilitation services utilization in individuals with cerebral palsy.Taiwan Master Master's Thesis
- BackgroundLevitt, S. (2013). Treatment of cerebral palsy and motor delay. John Wiley & Sons.
- BackgroundChing-Yi Chen,Ching-Chun Li,Jiunn-Horng Kang(2013). Medical Utilization among Patients with Cerebral Palsy, Taiwan Journal of Physical Medicine and Rehabilitation41(4), 225-234.
- Background: PubMed 1463061McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
- Background: PubMed 16915877Asher AV. Handwriting instruction in elementary schools. Am J Occup Ther. 2006 Jul-Aug;60(4):461-71. doi: 10.5014/ajot.60.4.461.
- 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.
Jui chi Lin, master study chair
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-assisted hand rehabilitation in people with Cerebral Palsy, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 6 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 12 Jul 2019. 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 Taiwan. 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?
Fugl-Meyer Assessment:Upper Limb section (time frame: Change from baseline to 6 weeks, follow up at one month). 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 NCT03490591, which also lists 26 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 12 Jul 2019.