Spastic Cerebral PalsyNCT02359799
Robotic Rehabilitation of Cerebral Palsy
A study testing IntelliStretch in people with Spastic Cerebral Palsy, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of the study is to examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for impaired ankles in cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- IntelliStretch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2019to 28 Feb 2023
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic cerebral palsy with diplegia or hemiplegia (affected both legs or one leg)
- 6-17 years old
- Can follow instructions and express any discomfort during the sessions.
Who cannot join
- Orthopedic surgery, serial casting, or injection of muscle relaxants such as botulinum toxin type A within 6 months prior to participation in the study
- Severe ankle contracture, greater than 20° plantar flexion
- Other unrelated neurological impairments or musculoskeletal injuries
- Can not sit for 1 hour
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Home- and Lab-Based Passive and Active Movement Rehabilitation of Ankle Impairments in Children With Cerebral Palsy
The purpose of the study is to examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for impaired ankles in cerebral palsy. Children with spastic cerebral palsy (CP) are randomly placed into two groups, participating in robot-guided stretching and active movement training either in a research lab setting (Lab group) or in a home setting (Home group).
Read the detailed description
Children with spastic CP will be randomly placed to 2 groups, either a Lab group or a Home group. For both groups, the participation will involve 18 training sessions over 6 weeks with 3 sessions each week. Each training session will last about 45 minutes, including stretching and active movement training.
The participant will be asked to sit with the foot secured to a footplate and leg fixed by a leg-support. Once the rehab robot is on the child's ankle, the investigator will first determine maximum range of motion that is safe for the ankle stretching. The robot will then move the ankle joint slowly within the set range of motion, and stretch the ankle back and forth. The passive stretching will help loosen the child's muscle and increase range of motion in the ankle joint. Passive stretching will last about 15 minutes.
After stretching, the investigator will ask the child to move and control the ankle joint back and forth to complete video-game tasks. While the child moves the ankle, the robot will provide assistance or resistance to improve control of the ankle joint. Active movement training will last about 20 minutes.
For Home group, the family members will be trained by the research team at the lab on how they use the rehab robot properly. On the day of the first assessment, the investigator will go through the device operation with family members. A detailed user manual will be given. The investigator will allow the family members and the child to practice using the device as many times as needed until the participant feel comfortable using the device at home. The family members should prepare for a minimum of one hour for this instructional period to learn the device, but they will be allowed as much time as needed.
Before leaving UMB to begin at-home training, the family members will be checked for the competency of using the device. The family members will be asked to go through each step without any direct assistance with the research staff. The family members may use their own vehicle to take the portable rehab robot home. While the family members are doing training for the child at home, the training data will be saved automatically in the laptop with the rehab robot.
Only one ankle joint will be allowed to treat using this robotic device. The investigator will choose the more impaired side ankle of the child to start the training. The investigator will follow up with the family members 1-3 times per week to check in regarding the child's participation and any issues during the training. The family members can also call the research staff if they have any questions about the training. The family members should follow the same training plan during 18 training sessions unless the investigator decide to adjust the training setups based on the child's progress.
Outcome assessments
During the study, the child will have 3 assessment visits in the research lab. The visits will occur before and after 6-week training, and at a follow-up 6 weeks after the training ends. During the assessment, the child's ankle will be moved by the robot to test passive range of motion and joint stiffness. The participant will also move the ankle himself and the active range of motion and muscle strength will be recorded. Clinical exam scales will be done including modified Ashworth scale, Selective Control Assessment of Lower Extremity (SCALE), balance, and walking ability (distance covered in 6 minutes).
- Conditions
- Spastic Cerebral Palsy
- Being tested
- IntelliStretch
- Keywords
- Cerebral palsy, Ankle Impairments, Robotic rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntelliStretchDevice
The impaired ankle of the participants are trained 3 times a week for 6 weeks in the lab or at home. The participants use the portable robotic device to stretch the ankle and increase range of motion (ROM). Then subjects use their gained ROM immediately in the active movement training to play video games and improve motor control.
| Study group | Role | What they receive |
|---|---|---|
| Lab group | Experimental | Lab-based intervention includes 18 training sessions using the IntelliStretch in the lab . Receives: Device: IntelliStretch |
| Home group | Experimental | Home-based intervention includes 18 training sessions using the IntelliStretch at home. Receives: Device: IntelliStretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Active Range of Motion (AROM)
The subjects will be asked to use their muscles to move the ankle joint and record the range of motion by the robot.
Measured: AROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Secondary outcomes (7)
Changes of Modified Ashworth Scale (MAS)
The MAS measures spasticity in patients with lesions of the Central Nervous System.
Measured: MAS will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of Selective Control Assessment of Lower Extremity (SCALE)
SCALE is a clinical assessment developed to quantify selective voluntary motor control in patients with cerebral palsy
Measured: SCALE will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of Pediatric Balance Scale (PBS)
PBS is a 14-item criterion-referenced measure that examines functional balance in the context of everyday tasks in the pediatric population.
Measured: PBS will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of the Timed Up and Go Test (TUG)
TUG assesses mobility, balance, walking ability, and fall risk.
Measured: TUG will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of 6 Minute Walk Test (6MWT)
The test assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Measured: 6MWT will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of Passive Range of Motion (PROM)
The robot will move the ankle joint of the subjects and record the range of motion.
Measured: PROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of the muscle strength
Dorsiflexor and plantarflexor strength will be measured with the ankle keeping held at 0° dorsiflexion.
Measured: The muscle strength will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study start21 Jun 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Qun Zhang, University of Maryland, Baltimore
- Investigators
- Li-Qun Zhang, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359799
- Sponsor's protocol ID
- HP-00079369
- Status last verified
- Apr 2023
- First submitted
- 26 Jan 2015
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Engsberg JR, Ross SA, Olree KS, Park TS. Ankle spasticity and strength in children with spastic diplegic cerebral palsy. Dev Med Child Neurol. 2000 Jan;42(1):42-7. doi: 10.1017/s0012162200000086.
PubMed 10665974Krebs HI, Hogan N, Aisen ML, Volpe BT. Robot-aided neurorehabilitation. IEEE Trans Rehabil Eng. 1998 Mar;6(1):75-87. doi: 10.1109/86.662623.
PubMed 9535526Damiano DL, Alter KE, Chambers H. New clinical and research trends in lower extremity management for ambulatory children with cerebral palsy. Phys Med Rehabil Clin N Am. 2009 Aug;20(3):469-91. doi: 10.1016/j.pmr.2009.04.005.
PubMed 19643348Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
PubMed 23962350Zhang M, Davies TC, Xie S. Effectiveness of robot-assisted therapy on ankle rehabilitation--a systematic review. J Neuroeng Rehabil. 2013 Mar 21;10:30. doi: 10.1186/1743-0003-10-30.
PubMed 23517734Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305.
PubMed 16344031Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22.
PubMed 21343525Willerslev-Olsen M, Andersen JB, Sinkjaer T, Nielsen JB. Sensory feedback to ankle plantar flexors is not exaggerated during gait in spastic hemiplegic children with cerebral palsy. J Neurophysiol. 2014 Feb;111(4):746-54. doi: 10.1152/jn.00372.2013. Epub 2013 Nov 13.
PubMed 24225545Geiger R, Strasak A, Treml B, Gasser K, Kleinsasser A, Fischer V, Geiger H, Loeckinger A, Stein JI. Six-minute walk test in children and adolescents. J Pediatr. 2007 Apr;150(4):395-9, 399.e1-2. doi: 10.1016/j.jpeds.2006.12.052.
PubMed 17382117Ballaz L, Plamondon S, Lemay M. Ankle range of motion is key to gait efficiency in adolescents with cerebral palsy. Clin Biomech (Bristol). 2010 Nov;25(9):944-8. doi: 10.1016/j.clinbiomech.2010.06.011. Epub 2010 Jul 23.
PubMed 20655641Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6.
PubMed 21211873Mankodi A, Azzabou N, Bulea T, Reyngoudt H, Shimellis H, Ren Y, Kim E, Fischbeck KH, Carlier PG. Skeletal muscle water T2 as a biomarker of disease status and exercise effects in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2017 Aug;27(8):705-714. doi: 10.1016/j.nmd.2017.04.008. Epub 2017 Apr 28.
PubMed 28601553Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016/j.apmr.2014.04.010. Epub 2014 May 2.
PubMed 24792141Chiu HC, Ada L, Bania TA. Mechanically assisted walking training for walking, participation, and quality of life in children with cerebral palsy. Cochrane Database Syst Rev. 2020 Nov 18;11(11):CD013114. doi: 10.1002/14651858.CD013114.pub2.
PubMed 33202482Chen K, Wu YN, Ren Y, Liu L, Gaebler-Spira D, Tankard K, Lee J, Song W, Wang M, Zhang LQ. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1237-43. doi: 10.1016/j.apmr.2016.01.029. Epub 2016 Feb 20.
PubMed 26903143
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home- and Lab-Based Passive and Active Movement Rehabilitation of Ankle Impairments in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02359799
- Acronym / sponsor ID
- HP-00079369
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Cerebral palsy, Ankle Impairments, Robotic rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Feb 2015 (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 purpose of the study is to examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for impaired ankles in cerebral palsy. Children with spastic cerebral palsy (CP) are randomly placed into two groups, participating in robot-guided stretching and active movement training either in a research lab setting (Lab group) or in a home setting (Home group).
Detailed description
Children with spastic CP will be randomly placed to 2 groups, either a Lab group or a Home group. For both groups, the participation will involve 18 training sessions over 6 weeks with 3 sessions each week. Each training session will last about 45 minutes, including stretching and active movement training.
The participant will be asked to sit with the foot secured to a footplate and leg fixed by a leg-support. Once the rehab robot is on the child's ankle, the investigator will first determine maximum range of motion that is safe for the ankle stretching. The robot will then move the ankle joint slowly within the set range of motion, and stretch the ankle back and forth. The passive stretching will help loosen the child's muscle and increase range of motion in the ankle joint. Passive stretching will last about 15 minutes.
After stretching, the investigator will ask the child to move and control the ankle joint back and forth to complete video-game tasks. While the child moves the ankle, the robot will provide assistance or resistance to improve control of the ankle joint. Active movement training will last about 20 minutes.
For Home group, the family members will be trained by the research team at the lab on how they use the rehab robot properly. On the day of the first assessment, the investigator will go through the device operation with family members. A detailed user manual will be given. The investigator will allow the family members and the child to practice using the device as many times as needed until the participant feel comfortable using the device at home. The family members should prepare for a minimum of one hour for this instructional period to learn the device, but they will be allowed as much time as needed.
Before leaving UMB to begin at-home training, the family members will be checked for the competency of using the device. The family members will be asked to go through each step without any direct assistance with the research staff. The family members may use their own vehicle to take the portable rehab robot home. While the family members are doing training for the child at home, the training data will be saved automatically in the laptop with the rehab robot.
Only one ankle joint will be allowed to treat using this robotic device. The investigator will choose the more impaired side ankle of the child to start the training. The investigator will follow up with the family members 1-3 times per week to check in regarding the child's participation and any issues during the training. The family members can also call the research staff if they have any questions about the training. The family members should follow the same training plan during 18 training sessions unless the investigator decide to adjust the training setups based on the child's progress.
Outcome assessments
During the study, the child will have 3 assessment visits in the research lab. The visits will occur before and after 6-week training, and at a follow-up 6 weeks after the training ends. During the assessment, the child's ankle will be moved by the robot to test passive range of motion and joint stiffness. The participant will also move the ankle himself and the active range of motion and muscle strength will be recorded. Clinical exam scales will be done including modified Ashworth scale, Selective Control Assessment of Lower Extremity (SCALE), balance, and walking ability (distance covered in 6 minutes).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lab group | Experimental | Device: IntelliStretchLab-based intervention includes 18 training sessions using the IntelliStretch in the lab . |
| Home group | Experimental | Device: IntelliStretchHome-based intervention includes 18 training sessions using the IntelliStretch at home. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Spastic cerebral palsy with diplegia or hemiplegia (affected both legs or one leg)
- 6-17 years old
- Can follow instructions and express any discomfort during the sessions.
Key exclusion criteria (4 listed)
- Orthopedic surgery, serial casting, or injection of muscle relaxants such as botulinum toxin type A within 6 months prior to participation in the study
- Severe ankle contracture, greater than 20° plantar flexion
- Other unrelated neurological impairments or musculoskeletal injuries
- Can not sit for 1 hour
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 |
|---|---|---|
| IntelliStretchThe impaired ankle of the participants are trained 3 times a week for 6 weeks in the lab or at home. The participants use the portable robotic device to stretch the ankle and increase range of motion (ROM). Then subjects use their gained ROM immediately in the active movement training to play video games and improve motor control. | Device | Home group, Lab group |
Primary outcome
Changes of Active Range of Motion (AROM)
Time frame: AROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
The subjects will be asked to use their muscles to move the ankle joint and record the range of motion by the robot.
7 secondary outcomes
Changes of Modified Ashworth Scale (MAS)
Time frame: MAS will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of Selective Control Assessment of Lower Extremity (SCALE)
Time frame: SCALE will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of Pediatric Balance Scale (PBS)
Time frame: PBS will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of the Timed Up and Go Test (TUG)
Time frame: TUG will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of 6 Minute Walk Test (6MWT)
Time frame: 6MWT will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of Passive Range of Motion (PROM)
Time frame: PROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
Changes of the muscle strength
Time frame: The muscle strength will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
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 13 Apr 2023.
- Background: PubMed 10665974Engsberg JR, Ross SA, Olree KS, Park TS. Ankle spasticity and strength in children with spastic diplegic cerebral palsy. Dev Med Child Neurol. 2000 Jan;42(1):42-7. doi: 10.1017/s0012162200000086.
- Background: PubMed 9535526Krebs HI, Hogan N, Aisen ML, Volpe BT. Robot-aided neurorehabilitation. IEEE Trans Rehabil Eng. 1998 Mar;6(1):75-87. doi: 10.1109/86.662623.
- Background: PubMed 19643348Damiano DL, Alter KE, Chambers H. New clinical and research trends in lower extremity management for ambulatory children with cerebral palsy. Phys Med Rehabil Clin N Am. 2009 Aug;20(3):469-91. doi: 10.1016/j.pmr.2009.04.005.
- Background: PubMed 23962350Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
- Background: PubMed 23517734Zhang M, Davies TC, Xie S. Effectiveness of robot-assisted therapy on ankle rehabilitation--a systematic review. J Neuroeng Rehabil. 2013 Mar 21;10:30. doi: 10.1186/1743-0003-10-30.
- Background: PubMed 16344031Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305.
- Background: PubMed 21343525Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22.
- Background: PubMed 24225545Willerslev-Olsen M, Andersen JB, Sinkjaer T, Nielsen JB. Sensory feedback to ankle plantar flexors is not exaggerated during gait in spastic hemiplegic children with cerebral palsy. J Neurophysiol. 2014 Feb;111(4):746-54. doi: 10.1152/jn.00372.2013. Epub 2013 Nov 13.
- Background: PubMed 17382117Geiger R, Strasak A, Treml B, Gasser K, Kleinsasser A, Fischer V, Geiger H, Loeckinger A, Stein JI. Six-minute walk test in children and adolescents. J Pediatr. 2007 Apr;150(4):395-9, 399.e1-2. doi: 10.1016/j.jpeds.2006.12.052.
- Background: PubMed 20655641Ballaz L, Plamondon S, Lemay M. Ankle range of motion is key to gait efficiency in adolescents with cerebral palsy. Clin Biomech (Bristol). 2010 Nov;25(9):944-8. doi: 10.1016/j.clinbiomech.2010.06.011. Epub 2010 Jul 23.
- Background: PubMed 21211873Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6.
- Background: PubMed 28601553Mankodi A, Azzabou N, Bulea T, Reyngoudt H, Shimellis H, Ren Y, Kim E, Fischbeck KH, Carlier PG. Skeletal muscle water T2 as a biomarker of disease status and exercise effects in patients with Duchenne muscular dystrophy. Neuromuscul Disord. 2017 Aug;27(8):705-714. doi: 10.1016/j.nmd.2017.04.008. Epub 2017 Apr 28.
- 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.
Li-Qun Zhang, Ph.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IntelliStretch in people with Spastic Cerebral Palsy, run by University of Maryland, Baltimore at 1 site in United States.
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 3 inclusion and 4 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 13 Apr 2023. 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 United States. 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?
Changes of Active Range of Motion (AROM) (time frame: AROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.). 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 NCT02359799, which also lists 15 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 13 Apr 2023.