Study Results
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Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2019-06-21
2023-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lab group
Lab-based intervention includes 18 training sessions using the IntelliStretch in the lab .
IntelliStretch
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.
Home group
Home-based intervention includes 18 training sessions using the IntelliStretch at home.
IntelliStretch
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.
Interventions
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IntelliStretch
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.
Eligibility Criteria
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Inclusion Criteria
2. 6-17 years old
3. Can follow instructions and express any discomfort during the sessions.
Exclusion Criteria
2. Severe ankle contracture, greater than 20° plantar flexion
3. Other unrelated neurological impairments or musculoskeletal injuries
4. Can not sit for 1 hour
6 Years
17 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Li-Qun Zhang
Professor
Principal Investigators
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Li-Qun Zhang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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University of Maryland, Baltimore
Baltimore, Maryland, United States
Countries
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References
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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.
Krebs 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.
Damiano 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.
Novak 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.
Zhang 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.
Selles 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.
Wu 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.
Willerslev-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.
Geiger 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.
Ballaz 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.
Gao 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.
Mankodi 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.
Sukal-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.
Chiu 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.
Chen 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.
Other Identifiers
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HP-00079369
Identifier Type: -
Identifier Source: org_study_id
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