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Not yet recruitingNCT07935967CPMCPUpdated Nov 13, 2026

Continuous Passive Motion on Upper Limb Spasticity and Hand Function in Children With Hemiplegic Cerebral Palsy

An interventional study of continuous passive movement device (CPM) in Hand Function Impairment, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 9 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

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

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
9 Years to 12 Years
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity and hand function in children with hemiplegic cerebral palsy.

The main questions it aims to answer are:

Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?

Read the detailed description

Cerebral palsy (CP) is a common underlying factor contributing to motor impairment in children. CP has frequently changed over the years. The most recent definition of CP is a collection of lasting irregularities in the development of movement and body positioning that result in activity restrictions for the affected person (Sadowska et al.,2020).

Hemiplegia is a neurological disorder that is frequently detected in children with CP. It may provoke altered selective motor control, weakness, and spasticity. While one side is affected by the disorder, the contralateral side appears to maintain complete functionality. The consequent asymmetry has been proven to affect many daily-life tasks, such as walking (DiNardo et al., 2019).

To date, little research examined the effect of Continuous passive motion (CPM) on functional impairment for upper extremity in CP children with hemiplegia. In addition to the economic changes in our society and increase of the cost of physical therapy session push us to investigate the immediate effect of physical therapy techniques and modalities and determine its validity in order to decrease physical therapy period and cost and improve its effectiveness.

Thus, outcomes of this study will be beneficial to determine the effect of CPM may be effective in the treatment of upper extremity in children with hemiplegia.

Statement of the problem:

Does continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy?

Purpose of the study:

The Purpose of the study was:

  1. To evaluate the effect of Continuous passive motion (CPM) on upper limb spasticity in children with hemiplegic cerebral palsy.
  2. To evaluate hand function in children with hemiplegic cerebral palsy. The selected subjects will be divided randomly by sealed envelopes into two groups of equal number; thirty children for each group. Participants received 1 hour and 30 minutes per day, 3 days/week for 3 month.

    • Study group :

Children of this group will receive specially designed physical therapy program and occupational therapy program in addition to continuous passive movement for the affected upper limb.

-control group : Children of this group will receive only specially designed physical therapy program and occupational therapy program.

Inclusive criteria:

The subjects will be included if:

  • Their age will be ranged from 9-12 years.
  • They are diagnosed with hemiplegic cerebral palsy.
  • The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
  • Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
  • They will be able to understand orders given to them.
02

Conditions studied

  • Hand Function Impairment

Keywords

  • continuous passive motion (CPM) have an effect on upper li cerebral palsy
  • continuous passive motion , upper limb spasticity ,hemiplegic CP
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,951 studies on the registry; 1,463 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
9 Years to 12 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

  • The subjects will be included if:
  • Their age will be ranged from 9 -12 years.
  • They are diagnosed with hemiplegic cerebral palsy.
  • The degree of spasticity; grade 2 according to modified Ashworth scale (Bohanon and Smith, 1987). (Appendix I)
  • Manual ability to handle objects in daily activities will be at level III according to Manual Ability Classification System (MACS) (Eliasson et al., 2006). (Appendix II)
  • They will be able to understand orders given to them.

Exclusion criteria

Exclusion Criteria:

  • The subjects will be excluded if they:
  • fixed deformities in the spine and/or upper extremities or suffering from Seizures.
  • visual nor auditory problems.
  • perceptual or cognitive problems.
  • injected by BOTOX in deltoid or biceps brachii muscles at the last 6 months
  • have surgical interference in upper limbs and/or spine at the last year.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    study group

    -Study group: Children will receive specially designed physical therapy program + occupational therapy program in addition to continuous passive movement (CPM) for the affected upper limb. 1.5 hours/day, 3 days/week for 3 months.

    Device: continuous passive movement device (CPM)

  • Active comparator
    Control group

    Children will receive only the specially designed physical therapy program + occupational therapy program 1.5 hours/day, 3 days/week for 3 months.

    Device: continuous passive movement device (CPM)

Interventions

  • Devicecontinuous passive movement device (CPM)

    * study group: Children will receive specially designed physical therapy program + occupational therapy program in addition to continuous passive movement (CPM) for the affected upper limb. 1.5 hours/day, 3 days/week for 3 months. * Control Group Children will receive only the specially designed physical therapy program + occupational therapy program 1.5 hours/day, 3 days/week for 3 months.

06

What researchers measure

Primary outcomes

  1. Hand functions

    Hand functions as manual dexterity, fine motor precision and fine motor integration will be assessed using Bruininks- Oseretsky Test of Motor Proficiency 2nd Edition

    Time frame: 45-60 minutes

Secondary outcomes

  1. Spasticity of upper limb

    Spasticity will be assessed using electromyographic apparatus (H/M ratio )

    Time frame: 10 minutes

  2. strength of biceps and deltoid

    Lafayette (hand held dynamometer)

    Time frame: 15 minutes

07

Study locations

1 site
  • Faculty of physical therapy Dokki,Giza Egypt
    Giza, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2026; primary completion for Jan 2027, 1 month later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2026
First posted
Nov 13, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Jan 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935967
Lead sponsor
Cairo University
Responsible party
Eman Fathy Mohamed Awad (continuous passive motion (CPM) have an effect on upper limb spasticity and hand function in children with hemiplegic cerebral palsy, Cairo University) — Principal investigator
First posted
Nov 13, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Jan 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Eman Fathy Mohamed, Doctoral Degree
Contact
doctoreman.fathy123@gmail.com
+201124424650
Gehan Hassan El-Meniawy, Professor
Contact
ggelmeniawy@Gmail.com
+201111801114
Eman Fathy Mohamed, dectoral degree
principal investigator · El salam university

Oversight

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

Not currently enrolling

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