ClinicalTrials.gg
CompletedNCT06339099Updated Sep 19, 2024

Loaded Gait Training on Gross Motor Function in Cerebral Palsy

An interventional study of Conventional physical therapy program and Loaded gait training in Cerebral Palsy, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
5 Years to 7 Years
Sex
All
01

Study summary

A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy. Children were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training. Gross motor functions and knee extensor strength were measured.

Read the detailed description

A randomized controlled trial aimed to evaluate the additional effect loaded gait training to conventional physical therapy program on gross motor function and the knee extensors strength in children with bilateral spastic cerebral palsy (CP).

52 children with bilateral spastic CP, aged 5 to 7 years, were divided randomly into two equal groups. The control group received a conventional physical therapy program, while the intervention group received the same program plus loaded gait training 3 times per week for an hour for 3 months.

Gross motor functions were measured by the Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains, while knee extensor strength was measured by a hand-held dynamometer.

02

Conditions studied

  • Cerebral Palsy

Browse trials for

Keywords

  • Bilateral spastic CP,
  • Gross motor function
  • Knee extensor strength
  • Loaded gait training
03

In context

Cerebral Palsy

1,894 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's enrollment of 52 is above the median of 34 across 1,396 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: five to seven years old, classified as levels II and III on the GMFCS.
  • Spasticity grade from 1+ to 2 based on the Modified Ashworth scale.
  • Able to understand and follow verbal commands and instructions (with a score above 80 on the Stanford Binet Intelligence Scale).

Exclusion criteria

Exclusion Criteria:

  • Genetic or metabolic disorders.
  • Brain tumours.
  • Musculoskeletal dysfunction that would interfere with our intervention (e.g. tightness of the posterior knee joint capsule that causes passive knee extension lag, or fixed contracture of the knee joint).
  • Surgical intervention in the lower limbs within the preceding 12 months.
  • Botulinum toxin injections in lower limb muscles within the last six months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    control arm

    The control group (n=26) received a conventional physical therapy program.

    Other: Conventional physical therapy program

  • Active comparator
    Intervention arm

    The intervention group (n=26) received conventional physical therapy program and loaded gait training.

    Other: Conventional physical therapy program · Other: Loaded gait training

Interventions

  • OtherConventional physical therapy program

    This program included active resisted strengthening exercises for pelvis girdle and lower limb muscles, stretching exercises of tight muscles of lower limbs; hip flexors, hamstrings and calf muscle, balance activities from standing and walking and gait training exercises.

  • OtherLoaded gait training

    An extra weight was added around the distal legs during gait training in the intervention group. This weight began at 0.5 kg and was gradually increased every two weeks to a maximum of 2 kg

06

What researchers measure

Primary outcomes

  1. Gross motor function

    Gross Motor Function Measure Scale-88 (GMFM-88); standing and walking domains.

    Time frame: 1 year

  2. knee extensor strength

    Knee extensor strength was measured by a hand-held dynamometer.

    Time frame: 1 year

07

Study locations

1 site
  • Faculty of Physical Therapy, Cairo University
    Giza, Cairo Governorate 12613, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06339099
Lead sponsor
Cairo University
Responsible party
Amina Awad,PhD (Associate Professor, Cairo University) — Principal investigator
First posted
Apr 1, 2024
Start date
Apr 2, 2024
Primary completion
Aug 15, 2024
Completion
Aug 30, 2024
Last update
Sep 19, 2024

Study contacts

Radwa S Abdul-Rahman, PhD
principal investigator · Faculty of Physical Therapy, Cairo University, Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion