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

University of Sharjah

Status: Not yet enrolling

Conditions: Cerebral Palsy Spastic Diplegia

Treatments: Other: Robotic assisted gait training

Study type: Interventional

Funder types: Other

Identifiers

NCT05412485

REC-21-06-22-01-S

Details and patient eligibility

About

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.

Full description

Cerebral palsy (CP) is defined as a group of disorders that affect mobility and posture with heterogeneous impairments such as muscle tone alternation, reduced selective motor control, joint contracture, postural control impairment and weakness of muscles. Independent walking is a priority goal for a lot of parents and children with CP.

RAGT has been considered as a revolutionary technology for gait enhancement. Lokomat, as one of RAGT devices, provides the intensive gait training with a number of repetitions of stepping while it preserves consistent pattern of movement. Lokomat with additional virtual reality games adds fun and challenge and enhances the involvement and motivation throughout the whole session. We will use Lokomat for RAGT for 6 weeks phase for both treatement and control groups. Only difference between groups is the frequency: 4 times a week for treatment group and 2 times a week for intervention group.

General gait and standing function will be measured by Gross motor function measure dimension E and D. Speed, endurance, balance, and quality of gait would be measured by 10 meter walk test, 6 minutes walk test, pediatric balance scale, and Edinburgh visual gait score. To our knowledge no previous studies investigated the effect of the increased frequency in RAGT with lokomat on improving gait speed, endurance, balance and quality in children with CP.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Other: Robotic assisted gait training

Control group

Active Comparator group

Description:

The same procedures will be given twice a week frequency.

Treatment:

Other: Robotic assisted gait training