The Effectiveness of Robotic Assisted Gait Training as an Adjunct to Traditional Physiotherapy in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Intervention name(s): Lokomat training
Intervention type(s): Device
Intervention description(s): Control group will receive the routine conventional physiotherapy treatment and the treatment for this group consists of the following:
Conventional therapy protocol:
5 sessions of 45 minutes a week, each session includes:
5 minutes of stretching exercise
20 minutes of strengthening exercise
10 minutes of balance exercise
10 minutes of gait training
Experimental group will receive 45 min of Lokomat in addition to the conventional approach (as explained above). Since Lokomat appointments can be only 8 per day, it is planned to have two groups of 8 participants for 4 weeks each. The Lokomat training include the following:
5 sessions of 45 minutes of conventional therapy (same as above) per week
5 sessions of 45 minutes on Lokomat per week
Other intervention name(s): Conventional therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Lokomat