Gait Improvement After Increased Frequency of Robot-assisted Gait Training in Cerebral Palsy Children

NCT05412485 | Unknown DMC

• 1 other identifier: REC-21-06-22-01-S
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Robot-assisted gait training (RAGT) can provide a longer training duration with a higher repetition of stepping while maintaining a stable pattern of movement. However, the existing evidence of its effectiveness is not clear. The aim of this study is to investigate the feasibility and the effect of increased frequency (4 times per week) of RAGT compared to the most common frequency (2 times per week). we hypothesize that increased frequency of RAGT will result in greater improvements on the gait functions. This research will investigate the effect of increased frequency on robotic assisted gait training (RAGT) in a frequency of 4 times per a week, and will compare the effect of robotic assisted gait training (RAGT) with increased frequency and with usual frequency (2 times per a week) in regards with gait functional parameters such as balance, speed, endurance, and quality of gait among cerebral palsy (CP) children's.

Conditions

Cerebral Palsy Spastic Diplegia

Keywords

Randomized pilot study; Cerebral palsy; Robotic assisted gait training; gait function

Outcome Measures

Primary Outcomes (5)

• The change in Gross motor function measure - Dimension E (GMFM E) between pre-treatment and post-treatment

  it evaluates 24 items which assess the ability of walking, running and jumping and 4 points ordinals scale (0 to 3) will be scored. A scoring key of 0 "does not initiate", 1 "initiates", 2 "partially completes", 3 "completed" is used. The score will be calculated into percentage. The possible score range is 0% to 100%. Higher percentage means better performance. An experienced physiotherapist in pediatric will instruct the children while video will be recorded.

  will be measured at two intervals; pre-treatment and immediately after treatment

• The change in Pediatric balance scale (PBS) between pre-treatment and post-treatment

  PBS is an adapted tool from berg balance scale to assess balance for children diagnosed with cerebral palsy (CP) with mild to moderate motor dysfunction. The scale is consisting of 14 items including siting, standing and change of position. 5 points ordinals scale (0 to 4) will be given. 0 is poorest and 4 is the best performance for each items. The participant will have 3 trials and the best of three trials will be considered for the scoring. Possible range of total score is 0 to 56.

  will be measured at two intervals; pre-treatment and immediately after treatment

• The change in Six minutes' walk test (6MWT) between pre-treatment and post-treatment

  6-miutes walk test will be performed to evaluate the endurance in 30-meter walkway with marked cones at each start and end point. It measures the distance a individual is able to walk over a total of six minutes in meter. The individual is allowed to self-pace and rest as needed as they traverse back an forth along a marked walkway.

  will be measured at two intervals; pre-treatment and immediately after treatment

• The change in Ten meter walk test (10MWT) between pre-treatment and post-treatment

  10MWT will be used to evaluate the gait speed in meter per second which is performed on 14- meter track with the use of walking aid if the child is using during ambulation. The participant will perform 3 trials and average time will be used for the speed in meter per second.

  will be measured at two intervals; pre-treatment and immediately after treatment

• The change in Edinburg visual gait score (EVGS) between pre-treatment and post-treatment

  EVGS assesses the gait quality and pattern by observation which can be used every day in practice in mobilizing children diagnosed with cerebral palsy when gait analysis instrument is not available. It's a tabulated system which can record 17 observational items for each lower extremity in which the selected items represent a feature of pathological gait of ambulatory children with cerebral palsy. Six anatomical level such as trunk , pelvis ,hip , knee and foot will be observed from recording video. Sagittal, coronal, and transverse planes will be assessed. The selected angle of the joint is calculated from data obtained during instrumented analysis gait of normal subject.

  will be measured at two intervals; pre-treatment and immediately after treatment

Secondary Outcomes (1)

• The change in Gross motor function measure - Dimension D (GMFM D) between pre-treatment and post-treatment

  will be measured at two intervals; pre-treatment and immediately after treatment

Study Arms (2)

Treatment group

EXPERIMENTAL

Lokomat Certified physiotherapists will perform robotic assisted gait trainings. It will be performed 4 times per a week with a duration of 30 minutes on the lokomat with a treatment of 6 weeks phase. Initially the Physical therapist will adjust the body -weight support at 70 % which will be gradually reduced until obtain flexion of the knees during stance phases. The lokomat certified physiotherapist will monitor the condition of the knees and adjust the body weight support during the training. The Gait speed will be set at 0.7 km/hour and will gradually increase according to the comfortable speed selected by the child. The gait speed, Body weight support and the guidance force of the Lokomat will be adjusted and modified individually according to the ability of the child. Virtual reality games will be used to motivate the participants and verbal encouragement will be used to increase their adherence to the intervention.

Other: Robotic assisted gait training

Control group

ACTIVE COMPARATOR

The same procedures will be given twice a week frequency.

Other: Robotic assisted gait training

Interventions

Robotic assisted gait training OTHER

Robotic assisted gait training is advanced technology used in the rehabilitation of neurological injuries and conditions like spinal cord injury, brain injury, stroke, multiple sclerosis, Parkinson's, cerebral palsy. It provides a repetitive task-specific motor training and modulates afferent input to spinal cord to generate rhythmic gait patterns that may be transformed to overground walking. The intensive repetitions of the rhythmic stepping movement during the training stimulates dependent plasticity and it may lead to brain reorganization. It facilitates cortical neural activities associated with motor control of walking.

Control group; Treatment group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with spastic diplegia; being able to walk independently with or without using walking aids on at least 10 meters; classified as level Ι, II and ΙΙΙ in the gross motor function classification system (GMFCS).
• Children who can follow instructions of gross motor function measure (GMFM) testing and able to express discomfort and pain by verbal or nonverbal signs, having required range for lokomat (hip and knee flexion contracture ≤10°, knee valgus ≤40°, femur length ≥ 23 cm).

You may not qualify if:

• If they received botulinum toxin injections or underwent surgical intervention at least a year before the 6-week of the intervention or participated in another Lokomat training regime within the last 3 months.
• If they have: (a) fixed contractures and/or with bone instability; (b) seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months); (c) baclofen infusion pumps in situ, open skin lesions and vascular disorder of lower extremities.

Sponsors & Collaborators

• University of Sharjah: lead

Study Sites (1)

University of Sharjah

University City, Emirate of Sharjah, United Arab Emirates

Location

Related Publications (5)

• Ammann-Reiffer C, Bastiaenen CH, Meyer-Heim AD, van Hedel HJ. Effectiveness of robot-assisted gait training in children with cerebral palsy: a bicenter, pragmatic, randomized, cross-over trial (PeLoGAIT). BMC Pediatr. 2017 Mar 2;17(1):64. doi: 10.1186/s12887-017-0815-y.

  PMID: 28253887 BACKGROUND

• Aurich-Schuler T, Warken B, Graser JV, Ulrich T, Borggraefe I, Heinen F, Meyer-Heim A, van Hedel HJ, Schroeder AS. Practical Recommendations for Robot-Assisted Treadmill Therapy (Lokomat) in Children with Cerebral Palsy: Indications, Goal Setting, and Clinical Implementation within the WHO-ICF Framework. Neuropediatrics. 2015 Aug;46(4):248-60. doi: 10.1055/s-0035-1550150. Epub 2015 May 26.

  PMID: 26011438 BACKGROUND

• Hilderley AJ, Fehlings D, Lee GW, Wright FV. Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Springerplus. 2016 Oct 28;5(1):1886. doi: 10.1186/s40064-016-3535-0. eCollection 2016.

  PMID: 27843743 BACKGROUND

• Jin LH, Yang SS, Choi JY, Sohn MK. The Effect of Robot-Assisted Gait Training on Locomotor Function and Functional Capability for Daily Activities in Children with Cerebral Palsy: A Single-Blinded, Randomized Cross-Over Trial. Brain Sci. 2020 Oct 30;10(11):801. doi: 10.3390/brainsci10110801.

  PMID: 33143214 BACKGROUND

• Lefmann S, Russo R, Hillier S. The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. J Neuroeng Rehabil. 2017 Jan 5;14(1):1. doi: 10.1186/s12984-016-0214-x.

  PMID: 28057016 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Meeyoung Kim, PhD

  University of Sharjah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meeyoung Kim, PhD

CONTACT

+97165057367; mkim@sharjah.ac.ae

Amal Ahboush, MSc

CONTACT

+97165057594; aahbouch@sharjah.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measure assessor will be blinded to the allocation. The child performance will be recorded and the score will be obtained by another assessor who is not aware about the date of the recorded video and not knowing of the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A prospective single blinded parallet-group, randomized clinical trial would be conducted.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 9, 2022
• Study Start: June 7, 2022
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: June 9, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After 6 months and will become availbel for one year
• Access Criteria: Not identified yet

Locations

AE (1)