NCT02359799

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
4.4 years until next milestone

Study Start

First participant enrolled

June 21, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

3.7 years

First QC Date

January 26, 2015

Last Update Submit

April 11, 2023

Conditions

Spastic Cerebral Palsy

Keywords

Cerebral palsyAnkle ImpairmentsRobotic rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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 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 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 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)

    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.

  • +2 more secondary outcomes

Study Arms (2)

Lab group

EXPERIMENTAL

Lab-based intervention includes 18 training sessions using the IntelliStretch in the lab .

Device: IntelliStretch

Home group

EXPERIMENTAL

Home-based intervention includes 18 training sessions using the IntelliStretch at home.

Device: IntelliStretch

Interventions

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.

Home groupLab group

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Spastic cerebral palsy with diplegia or hemiplegia (affected both legs or one leg)
  • years old
  • Can follow instructions and express any discomfort during the sessions.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (15)

  • 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.

    PMID: 10665974BACKGROUND

  • 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.

    PMID: 9535526BACKGROUND

  • 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.

    PMID: 19643348BACKGROUND

  • 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.

    PMID: 23962350BACKGROUND

  • 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.

    PMID: 23517734BACKGROUND

  • 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.

    PMID: 16344031BACKGROUND

  • 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.

    PMID: 21343525BACKGROUND

  • 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.

    PMID: 24225545BACKGROUND

  • 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.

    PMID: 17382117BACKGROUND

  • 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.

    PMID: 20655641BACKGROUND

  • 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.

    PMID: 21211873BACKGROUND

  • 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.

    PMID: 28601553BACKGROUND

  • 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.

    PMID: 24792141BACKGROUND

  • 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.

    PMID: 33202482DERIVED

  • 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.

    PMID: 26903143DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Li-Qun Zhang, Ph.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 10, 2015

Study Start

June 21, 2019

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)