Cerebral PalsyNCT01700153
Efficacy Study of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy
A study testing Robotic-assisted therapy and Classical therapy in people with Cerebral Palsy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Cerebral Palsy (CP) is a major cause of impairments in child population. This disease justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised by robotics. Our team has developed a robot designed to rehabilitate the child's upper limb. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Robotic-assisted therapy and Classical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2012to May 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cerebral palsy (hemi, quadri or di-plegia)
- MACS > 1/5 (moderate to severe impairments)
Who cannot join
- Botulinum toxin injection in the upper limb muscles
- Intrathecal Baclofen for the upper limb spasticity
- an unstable clinical condition contraindicating the upper limb rehabilitation treatments
- cognitive disorders preventing the understanding of the instructions
- other neurological or orthopedic pathology affecting the upper limb.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy by Evaluating the 3 Fields of the ICF: A Prospective, Randomized, Controlled, Simple Blind Study.
Cerebral Palsy (CP) is a major cause of impairments in child population. This disease justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised by robotics.
Our team has developed a robot designed to rehabilitate the child's upper limb. This robot allows the patient to perform active, passive, or assisted exercises.
Read more
This therapy is designed to promote motor development in children with CP. Its finality is to improve patients' quality of life and participation.
Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP but none RCT has been done.
Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the 3 fields of the ICF (International Classification of Functioning, Disability and Health) and performing a prospective randomized controlled single blind trial. Therefore, all patients will benefit from a classical rehabilitation as a basis. Furthermore, patients of the control and experimental groups will receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.
Read the detailed description
INTRODUCTION
Cerebral Palsy (CP) is a major cause of impairments in child population. Indeed, CP affects two births per thousand (1). The brain damage is expressed by different neurological impairments and functional disabilities. These disabilities justify intensive and sustained multidisciplinary rehabilitation to reduce neurological impairments, to improve the activities and participation of patients, and, ultimately, their quality of life (2, 3, 4).
Robotics interest has already been shown for lower limb rehabilitation (5). The development of the upper limb rehabilitation robotic devices started later. To better stimulate brain plasticity, these tools meet the actual recommendations existing in CP's rehabilitation (4). Indeed, the robots allow the execution of a large number of movements whose quality is controlled (6). A visual interface gives the patient a feedback of its movements (7), and offers exercises oriented functional tasks that have meaning for him (8) and the possibly dive into a virtual reality. All these elements justify the clinical development of robots to assist the therapists.
In children with CP, several pilot studies have verified the clinical applicability of these tools (9-11). However, no randomized controlled study has been performed to evaluate the effectiveness of robotic-assisted therapy in children with CP (12). Moreover, no study evaluated the effect of these therapies on the three areas of the ICF : Many studies focus on impairments (e.g. muscle) without assessing the functional capacity of the patient: what about their ability in every day life?
OBJECTIVES
To perform a prospective, randomized, controlled, single blind trial to assess the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of the ICF.
METHODS
Twenty patients enrolled at the "Institut Royal de l'Accueil du Handicap Moteur" (IRAHM) (1200 Brussels) will be included according to the following criteria: CP, whose location is unilateral (hemiplegia) or bilateral (diplegia, quadriplegia), with a MACS (Manual Ability Classification System) score > 1 (moderate to severe motor impairments) (13). The exclusion criteria are the following: injection in the upper member of botulinum toxin within 6 months or intrathecal baclofen used for the upper limb, an unstable clinical condition contraindicating the upper limb rehabilitation treatments, cognitive disorders preventing the understanding of the instructions or other neurological or orthopedic pathology affecting the upper limb.
A randomisation of patients in two groups (control and experimental) will be performed, using a stratified randomization method to ensure the equivalence of the two groups for age, the location of the symptoms (diplegia, quadriplegia, left or right hemiplegia) and motor neurological impairments (MACS score).
At IRAHM, each child benefits of 3 physiotherapy sessions and 2 occupational therapy sessions per week. Each session lasts 45 minutes. The children in the control group will see no change in their treatment. In the experimental group, 1 physiotherapy session and 1 occupational therapy session will be replaced by two sessions of intensive rehabilitation of the arm with the robot. In total for each group, each child will benefit from 40 sessions of 45 minutes over 8 weeks therapy
Patients will be evaluated three times in the study: before the start of treatments, at the end of treatments, and 3 months after the end of treatments.
Functional assessments will be carried out according to a protocol exploring the three fields of the ICF. Impairments will be evaluated by the score of Quality of Upper Extremity Skills Test (14), MACS (13), and the Box and Block test (15). Then, spasticity (with two scales), kinematics and strength of the paretic arm will be evaluated using the modified Ashworth and Tardieu scales, the ReaPLAN robot and a dynamometer, respectively (9, 16, 17). Disability will be evaluated via Abilhand-kids (18) and Pediatric Evaluation of Disability Inventory (19). Participation restrictions will be evaluated via the MHAVIE questionnaire (20). All assessments will be carried out by a occupational therapist, which will be not informed the group that the child is assigned (single-blind). All rehabilitation and assessment sessions will be conducted at the IRAHM.
PERSPECTIVES
From this study, we hope to demonstrate the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of the ICF. These results could prove that this tool can be a significant complement for the CP rehabilitation.
- Conditions
- Cerebral Palsy
- Being tested
- Robotic-assisted therapy, Classical therapy
- Keywords
- Robotic-assisted therapy, cerebral palsy, ICF
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic-assisted therapyOther
This robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient capacity.
Classical therapyOther
conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Robotic-assisted therapy | Experimental | All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of robotic-assisted therapy. Receives: Other: Robotic-assisted therapy; Other: Classical therapy |
| Classical therapy | Active comparator | All patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of classical rehabilitation. Receives: Other: Classical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic
Measured: Change from Baseline in Kinematic at an expected average of 3 months and 6 months
Secondary outcomes (7)
Manual Ability Classification System
Measured: Change from Baseline in manual ability at an expected average of 3 months and 6 months
Quality of Upper Extremity Skills Test
Measured: Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months
Box and Block test
Measured: Change from Baseline in dexterity at an expected average of 3 months and 6 months
strength
Measured: Change from Baseline in strength at an expected average of 3 months and 6 months
Abilhand-Kids scale
Measured: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
Pediatric Evaluation of Disability Inventory
Measured: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
MHAVIE
Measured: Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lejeune, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Maxime Gilliaux, PhD student, Principal investigator, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01700153
- Sponsor's protocol ID
- IONS-Gilliaux-01
- Status last verified
- May 2013
- First submitted
- 26 Sep 2012
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bax MC, Flodmark O, Tydeman C. Definition and classification of cerebral palsy. From syndrome toward disease. Dev Med Child Neurol Suppl. 2007 Feb;109:39-41. No abstract available.
PubMed 17370481Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
PubMed 16120836Ward NS. The neural substrates of motor recovery after focal damage to the central nervous system. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S30-5. doi: 10.1016/j.apmr.2006.08.334.
PubMed 17140877Aisen ML, Kerkovich D, Mast J, Mulroy S, Wren TA, Kay RM, Rethlefsen SA. Cerebral palsy: clinical care and neurological rehabilitation. Lancet Neurol. 2011 Sep;10(9):844-52. doi: 10.1016/S1474-4422(11)70176-4.
PubMed 21849165Mehrholz J, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006185. doi: 10.1002/14651858.CD006185.pub2.
PubMed 17943893Masiero S, Celia A, Rosati G, Armani M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):142-9. doi: 10.1016/j.apmr.2006.10.032.
PubMed 17270510Housman SJ, Scott KM, Reinkensmeyer DJ. A randomized controlled trial of gravity-supported, computer-enhanced arm exercise for individuals with severe hemiparesis. Neurorehabil Neural Repair. 2009 Jun;23(5):505-14. doi: 10.1177/1545968308331148. Epub 2009 Feb 23.
PubMed 19237734Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.
PubMed 22696362Krebs HI, Ladenheim B, Hippolyte C, Monterroso L, Mast J. Robot-assisted task-specific training in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:140-5. doi: 10.1111/j.1469-8749.2009.03416.x.
PubMed 19740222Fasoli 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 18936558Frascarelli F, Masia L, Di Rosa G, Cappa P, Petrarca M, Castelli E, Krebs HI. The impact of robotic rehabilitation in children with acquired or congenital movement disorders. Eur J Phys Rehabil Med. 2009 Mar;45(1):135-41.
PubMed 19293759Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
PubMed 19451190Eliasson AC, Krumlinde-Sundholm L, Rosblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. doi: 10.1017/S0012162206001162.
PubMed 16780622Klingels K, De Cock P, Desloovere K, Huenaerts C, Molenaers G, Van Nuland I, Huysmans A, Feys H. Comparison of the Melbourne Assessment of Unilateral Upper Limb Function and the Quality of Upper Extremity Skills Test in hemiplegic CP. Dev Med Child Neurol. 2008 Dec;50(12):904-9. doi: 10.1111/j.1469-8749.2008.03123.x. Epub 2008 Sep 20.
PubMed 18811701Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
PubMed 8024419
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effectiveness of an Interactive Robot for the Rehabilitation of the Upper Limb in Children With Cerebral Palsy by Evaluating the 3 Fields of the ICF: A Prospective, Randomized, Controlled, Simple Blind Study.
- ClinicalTrials.gov ID
- NCT01700153
- Acronym / sponsor ID
- IONS-Gilliaux-01
- Conditions
- Cerebral Palsy
- Keywords
- Robotic-assisted therapy, cerebral palsy, ICF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 4 Oct 2012 (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.
Cerebral Palsy (CP) is a major cause of impairments in child population. This disease justifies an intensive and prolonged multidisciplinary rehabilitation which can be optimised by robotics.
Our team has developed a robot designed to rehabilitate the child's upper limb. This robot allows the patient to perform active, passive, or assisted exercises.
This therapy is designed to promote motor development in children with CP. Its finality is to improve patients' quality of life and participation.
Several pilot studies evaluated the efficacy of robotic assisted therapy in children with CP but none RCT has been done.
Then, the aim of the study is to evaluate the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the 3 fields of the ICF (International Classification of Functioning, Disability and Health) and performing a prospective randomized controlled single blind trial. Therefore, all patients will benefit from a classical rehabilitation as a basis. Furthermore, patients of the control and experimental groups will receive a supplement of classical rehabilitation and robotic-assisted therapy, respectively.
Detailed description
INTRODUCTION
Cerebral Palsy (CP) is a major cause of impairments in child population. Indeed, CP affects two births per thousand (1). The brain damage is expressed by different neurological impairments and functional disabilities. These disabilities justify intensive and sustained multidisciplinary rehabilitation to reduce neurological impairments, to improve the activities and participation of patients, and, ultimately, their quality of life (2, 3, 4).
Robotics interest has already been shown for lower limb rehabilitation (5). The development of the upper limb rehabilitation robotic devices started later. To better stimulate brain plasticity, these tools meet the actual recommendations existing in CP's rehabilitation (4). Indeed, the robots allow the execution of a large number of movements whose quality is controlled (6). A visual interface gives the patient a feedback of its movements (7), and offers exercises oriented functional tasks that have meaning for him (8) and the possibly dive into a virtual reality. All these elements justify the clinical development of robots to assist the therapists.
In children with CP, several pilot studies have verified the clinical applicability of these tools (9-11). However, no randomized controlled study has been performed to evaluate the effectiveness of robotic-assisted therapy in children with CP (12). Moreover, no study evaluated the effect of these therapies on the three areas of the ICF : Many studies focus on impairments (e.g. muscle) without assessing the functional capacity of the patient: what about their ability in every day life?
OBJECTIVES
To perform a prospective, randomized, controlled, single blind trial to assess the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of the ICF.
METHODS
Twenty patients enrolled at the "Institut Royal de l'Accueil du Handicap Moteur" (IRAHM) (1200 Brussels) will be included according to the following criteria: CP, whose location is unilateral (hemiplegia) or bilateral (diplegia, quadriplegia), with a MACS (Manual Ability Classification System) score > 1 (moderate to severe motor impairments) (13). The exclusion criteria are the following: injection in the upper member of botulinum toxin within 6 months or intrathecal baclofen used for the upper limb, an unstable clinical condition contraindicating the upper limb rehabilitation treatments, cognitive disorders preventing the understanding of the instructions or other neurological or orthopedic pathology affecting the upper limb.
A randomisation of patients in two groups (control and experimental) will be performed, using a stratified randomization method to ensure the equivalence of the two groups for age, the location of the symptoms (diplegia, quadriplegia, left or right hemiplegia) and motor neurological impairments (MACS score).
At IRAHM, each child benefits of 3 physiotherapy sessions and 2 occupational therapy sessions per week. Each session lasts 45 minutes. The children in the control group will see no change in their treatment. In the experimental group, 1 physiotherapy session and 1 occupational therapy session will be replaced by two sessions of intensive rehabilitation of the arm with the robot. In total for each group, each child will benefit from 40 sessions of 45 minutes over 8 weeks therapy
Patients will be evaluated three times in the study: before the start of treatments, at the end of treatments, and 3 months after the end of treatments.
Functional assessments will be carried out according to a protocol exploring the three fields of the ICF. Impairments will be evaluated by the score of Quality of Upper Extremity Skills Test (14), MACS (13), and the Box and Block test (15). Then, spasticity (with two scales), kinematics and strength of the paretic arm will be evaluated using the modified Ashworth and Tardieu scales, the ReaPLAN robot and a dynamometer, respectively (9, 16, 17). Disability will be evaluated via Abilhand-kids (18) and Pediatric Evaluation of Disability Inventory (19). Participation restrictions will be evaluated via the MHAVIE questionnaire (20). All assessments will be carried out by a occupational therapist, which will be not informed the group that the child is assigned (single-blind). All rehabilitation and assessment sessions will be conducted at the IRAHM.
PERSPECTIVES
From this study, we hope to demonstrate the efficacy of robotic-assisted therapy in children with cerebral palsy by evaluating the three fields of the ICF. These results could prove that this tool can be a significant complement for the CP rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Robotic-assisted therapy | Experimental | Other: Robotic-assisted therapy, Other: Classical therapyAll patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of robotic-assisted therapy. |
| Classical therapy | Active comparator | Other: Classical therapyAll patients will receive a similar classical rehabilitation as a basis. the 10 patients of this group will receive a supplement of classical rehabilitation. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Cerebral palsy (hemi, quadri or di-plegia)
- MACS > 1/5 (moderate to severe impairments)
Key exclusion criteria (5 listed)
- Botulinum toxin injection in the upper limb muscles
- Intrathecal Baclofen for the upper limb spasticity
- an unstable clinical condition contraindicating the upper limb rehabilitation treatments
- cognitive disorders preventing the understanding of the instructions
- other neurological or orthopedic pathology affecting the upper limb.
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 |
|---|---|---|
| Robotic-assisted therapyThis robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient capacity. | Other | Experimental: Robotic-assisted therapy |
| Classical therapyconventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation | Other | Classical therapy, Experimental: Robotic-assisted therapy |
Primary outcome
Kinematic
Time frame: Change from Baseline in Kinematic at an expected average of 3 months and 6 months
7 secondary outcomes
Manual Ability Classification System
Time frame: Change from Baseline in manual ability at an expected average of 3 months and 6 months
Quality of Upper Extremity Skills Test
Time frame: Change from Baseline in quality of upper extremity skills at an expected average of 3 months and 6 months
Box and Block test
Time frame: Change from Baseline in dexterity at an expected average of 3 months and 6 months
strength
Time frame: Change from Baseline in strength at an expected average of 3 months and 6 months
Abilhand-Kids scale
Time frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
Pediatric Evaluation of Disability Inventory
Time frame: Change from Baseline in activity of daily living at an expected average of 3 months and 6 months
MHAVIE
Time frame: Change from Baseline in parents' satisfaction of children activity daily living at an expected average of 3 months and 6 months
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 8 May 2013.
- Background: PubMed 17370481Bax MC, Flodmark O, Tydeman C. Definition and classification of cerebral palsy. From syndrome toward disease. Dev Med Child Neurol Suppl. 2007 Feb;109:39-41. No abstract available.
- Background: PubMed 16120836Duncan PW, Zorowitz R, Bates B, Choi JY, Glasberg JJ, Graham GD, Katz RC, Lamberty K, Reker D. Management of Adult Stroke Rehabilitation Care: a clinical practice guideline. Stroke. 2005 Sep;36(9):e100-43. doi: 10.1161/01.STR.0000180861.54180.FF. No abstract available.
- Background: PubMed 17140877Ward NS. The neural substrates of motor recovery after focal damage to the central nervous system. Arch Phys Med Rehabil. 2006 Dec;87(12 Suppl 2):S30-5. doi: 10.1016/j.apmr.2006.08.334.
- Background: PubMed 21849165Aisen ML, Kerkovich D, Mast J, Mulroy S, Wren TA, Kay RM, Rethlefsen SA. Cerebral palsy: clinical care and neurological rehabilitation. Lancet Neurol. 2011 Sep;10(9):844-52. doi: 10.1016/S1474-4422(11)70176-4.
- Background: PubMed 17943893Mehrholz J, Werner C, Kugler J, Pohl M. Electromechanical-assisted training for walking after stroke. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006185. doi: 10.1002/14651858.CD006185.pub2.
- Background: PubMed 17270510Masiero S, Celia A, Rosati G, Armani M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch Phys Med Rehabil. 2007 Feb;88(2):142-9. doi: 10.1016/j.apmr.2006.10.032.
- Background: PubMed 19237734Housman SJ, Scott KM, Reinkensmeyer DJ. A randomized controlled trial of gravity-supported, computer-enhanced arm exercise for individuals with severe hemiparesis. Neurorehabil Neural Repair. 2009 Jun;23(5):505-14. doi: 10.1177/1545968308331148. Epub 2009 Feb 23.
- Background: PubMed 22696362Mehrholz J, Hadrich A, Platz T, Kugler J, Pohl M. Electromechanical and robot-assisted arm training for improving generic activities of daily living, arm function, and arm muscle strength after stroke. Cochrane Database Syst Rev. 2012 Jun 13;(6):CD006876. doi: 10.1002/14651858.CD006876.pub3.
- Background: PubMed 19740222Krebs HI, Ladenheim B, Hippolyte C, Monterroso L, Mast J. Robot-assisted task-specific training in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:140-5. doi: 10.1111/j.1469-8749.2009.03416.x.
- 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.
- Background: PubMed 19293759Frascarelli F, Masia L, Di Rosa G, Cappa P, Petrarca M, Castelli E, Krebs HI. The impact of robotic rehabilitation in children with acquired or congenital movement disorders. Eur J Phys Rehabil Med. 2009 Mar;45(1):135-41.
- Background: PubMed 19451190Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
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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.
Maxime Gilliaux, PhD student principal investigator
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic-assisted therapy and Classical therapy in people with Cerebral Palsy, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 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 8 May 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 Belgium. 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?
Kinematic (time frame: Change from Baseline in Kinematic at an expected average of 3 months and 6 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 NCT01700153, which also lists 20 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 8 May 2013.