Clinical trial NCT04960683: The Effectiveness of Robotic Assisted Gait Training as an Adjunct to Traditional Physiotherapy in Cerebral Palsy
Official title: The Effectiveness of Robotic Assisted Gait Training as an Adjunct to Traditional Physiotherapy in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Children
Lokomat
Lead sponsor: Fatima College of Health Sciences
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Need for study

There are a few studies published on this topic from various parts of the globe and the results are mixed. Hence further research is required in this area and none of the studies have included samples from the Middle East.

Some studies done in this area focus on biomechanical aspects of gait (Cherni, 2018) and our study mainly focuses on functional aspects of gait and quality of life.

Studies done on this area focus highly on gait components and very little is available on the literature on improving balance. Since balance and stability are crucial for walking, it was decided to exclusively assess balance.

Due to a wide range of therapeutic benefits, it is paramount to evaluate the effectiveness of different therapies provided to improve gait.

Aim of the study:

The aim of the proposed research is to investigate the effectiveness of robotic assisted gait training using Lokomat device as an adjunct in improving gait, balance and quality of life in children with cerebral palsy.

Detailed description: Background: Gait and balance have been a major issue faced by cerebral palsy children. Cerebral Palsy is the most common condition affecting around 2-2.5 children of 1000 live births (1 in every 400 children) over the last 20 years in the Western world (Levit, 2019). Cerebral Palsy causes complex issues related to physical, psychological and social functions. Active participation and the highest level of independence during daily living are primary goals for cerebral palsy children (Aurich, 2015). One of the major problems that limits activities of daily living is relate to gait and balance in cerebral palsy. From the past one-decade, the popularity of robotic assisted gait training devices have been increasing. There are a studies published on this topic from various parts of the globe and the results are mixed. Recent publications have demonstrated robotic assisted gait training benefits people with cerebral palsy, specifically in increasing walking speed and endurance (Carvalho, 2017). However, the efficacy of robotic assisted gait training in improving gait and balance is not well researched. This study will be the first one in the United Arab Emirates studying the local population and mainly focusing on functional aspects of gait, balance and quality of life.

Aims: The main aim is to investigate the effectiveness of robotic -assisted gait training as an adjunct to traditional physiotherapy to improve gait, balance and quality of life in children with cerebral palsy.

Research hypothesis: Robotic -assisted gait training applied as adjunct to traditional therapy could improve balance, walking and quality of life in children with cerebral palsy.

Methodology: The participants attending the outpatient clinic at Zayed Higher Organization for People of Determination, Abu Dhabi will be invited to take part in the study. They will be randomly allocated to two groups. This study proposes to have 50 participants with at least 25 in each group. The participants will all have spastic form of cerebral palsy as possible with the age of 4-18 years. All the participants will have to have be at Gross Motor Function Classification Level (GMFCS) level I- IV. The robotic -assisted gait training include 5 sessions per week, of 40 min long session during one-month period. The conventional physiotherapy includes 5 sessions per week of 40 min long session during one-month period. The primary analysis will be the pre to post-test differences of the Gross Motor Function Measure (GMFM-88),dimension D \& E, 10 meters walk test, 6 minute walk test, Pediatric Balance Scale, Cerebral palsy Quality of Life questionnaire between experimental and control group.

Data analysis: Data will be statistically analysed using one-way anova. Descriptive statistics and graphic displays will be present for all outcomes for interventions comparing robotic -assisted gait training with traditional physiotherapy training.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy with spastic and mix form

  * Gross Motor Function Classification System (GMFCS from level II to IV)
  * Age 4 to 18
  * No contraindications for the training in the Lokomat
  * Able to follow simple instructions

Exclusion Criteria:

* On botox injection within the last 6 months (as the effect of botox wear out in 6 months)

  * Surgery within the last one year
  * Fixed contractures and/or with bone instability
  * Baclofen infusion pumps in situ
  * Seizure disorder that is not controlled by medication (if on medication, must not have had a seizure in the last 12 months);
  * Open skin lesions or vascular disorder of lower extremities;
  * Having participated in another Lokomat training regime within the previous 3months as well as a change in concomitant treatment within the last 4 weeks before or during the study period

Primary outcomes:
measure: Gross Motor Function Measure ( GMFM- 88) - dimension D & dimension E
timeFrame: Baseline time 0 and up to 8 weeks
measure: 6 minute Walk test
timeFrame: Baseline time 0 and up to 8 weeks
measure: 10 meters Walk test
timeFrame: Baseline time 0 and up to 8 weeks
measure: Pediatric Balance Scale
timeFrame: Baseline time 0 and up to 8 weeks
measure: Cerebral Palsy Quality of Life questionnaire for child (CP QOL-child) and Cerebral Palsy Quality of Life questionnaire for adolescent (CP QOL- teen)
timeFrame: Baseline time 0 and up to 8 weeks
Secondary outcomes:
measure: Range of motion
timeFrame: Baseline time 0 and up to 8 weeks
measure: The Oxford scale
timeFrame: Baseline time 0 and up to 8 weeks
measure: Modified Ashworth Scale
timeFrame: Baseline time 0 and up to 8 weeks
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Fatima College of Health Sciences
Study officials:
affiliation: FCHS
name: Dragana Djuric
role: PRINCIPAL_INVESTIGATOR
References: