The Effectiveness of Robotic Assisted Gait Training as an Adjunct to Traditional Physiotherapy in Cerebral Palsy

NCT04960683 | Completed

• 1 other identifier: INTSTF018PHY20
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Children; Lokomat

Outcome Measures

Primary Outcomes (5)

• Gross Motor Function Measure ( GMFM- 88) - dimension D & dimension E

  This is the validated test designed to measure change in gross motor function over time in children with cerebral palsy. Dimension D consist of 13 items for standing ability and dimension E has 24 items to assess walking, jumping and running in cerebral palsy children. Its a four point scoring system. Specific descriptors for each score is given in the Manual of GMFM-88.

  Baseline time 0 and up to 8 weeks

• 6 minute Walk test

  The test has been selected as a measure of gait endurance. This is validated test requiring individuals to walk 6 minutes on flat hard floor. Scoring is walking distance.

  Baseline time 0 and up to 8 weeks

• 10 meters Walk test

  The test has been selected as a measure of gait speed. This is validated test requiring individuals to walk on flat hard floor at their comfortable speed for 10 meters.

  Baseline time 0 and up to 8 weeks

• Pediatric Balance Scale

  14 items valid scale is used to assess functional balance skills in children with spastic cerebral palsy.

  Baseline time 0 and up to 8 weeks

• Cerebral Palsy Quality of Life questionnaire for child (CP QOL-child) and Cerebral Palsy Quality of Life questionnaire for adolescent (CP QOL- teen)

  This Arabic validated CP QOL- child for age 4-12 and CP QOL- teen for age 13-18 questionnaires are used in the parent version. Its assesses 7 domains on a 9 level point Likert scale.

  Baseline time 0 and up to 8 weeks

Secondary Outcomes (3)

• Range of motion

  Baseline time 0 and up to 8 weeks

• The Oxford scale

  Baseline time 0 and up to 8 weeks

• Modified Ashworth Scale

  Baseline time 0 and up to 8 weeks

Study Arms (2)

Robotic -assisted gait training group using Lokomat device

EXPERIMENTAL

* 5 sessions of 40 minutes of conventional therapy and * 5 sessions of 40 minutes on Lokomat per week

Device: Lokomat training

Traditional therapy group

ACTIVE COMPARATOR

• 5 sessions of 40 minutes of conventional therapy

Device: Lokomat training

Interventions

Lokomat training DEVICE

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

Also known as: Conventional therapy

Robotic -assisted gait training group using Lokomat device; Traditional therapy group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatima College of Health Sciences: lead

Study Sites (1)

Fatima College of Health Sciences

Abu Dhabi, 3758, United Arab Emirates

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Dragana Djuric

  FCHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in physiotherapy

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: July 14, 2021
• Study Start: November 8, 2020
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 25, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)