NCT05596513

Brief Summary

Working on a vertical surface is one of the best activities children can do to make themselves more successful in many areas as an infant which builds all those foundational skills required for the all-important task of handwriting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 30, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

April 11, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

October 24, 2022

Last Update Submit

April 8, 2023

Conditions

Keywords

motor learningvertical surfacehemiplegiacerebral palsy

Outcome Measures

Primary Outcomes (1)

  • QUEST

    quality of upper extremity skills test (Only dissociated movement, grasp and weight bearing domains QUEST will be assessed).

    3 month

Study Arms (2)

control group

ACTIVE COMPARATOR

received intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) provide an alternative).

Other: motor learning and occupational therapy

study group

EXPERIMENTAL

received the intensive motor-learning approaches of the control group but from a vertical surface

Other: Motor Learning Approaches From Working on a Vertical Surface

Interventions

1. Constraint-induced movement therapy (CIMT) 2. Hand-arm bimanual intensive training (HABIT)

control group

1. Ball on wall, kneel to stand 2. Kneel walk cross over 3. Vertical playground puzzles and games 4. Color on big boxes 5. Fridge magnets 6. Erasing a whiteboard or chalkboard 7. Tactile feedback from textured walls

study group

Eligibility Criteria

Age5 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed with spastic hemiplegic cerebral palsy
  • Age 5 to 9 years
  • Manual Ability Classification System (MACS)19 scores I, II.
  • Children who can understand and cooperate with researcher's instructions
  • Children with no visual or hearing impairment

You may not qualify if:

  • Children with any surgical interference in the upper limb.
  • Intellectual disability such that simple tasks could not be understood or executed.
  • Inability to combine the study protocol with the regular school program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University

Badr, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

HemiplegiaMuscle SpasticityCerebral Palsy

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Omnya samy, PHD

    lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: received the intensive motor-learning approaches that focuses on training of the affected hand (motor-learning approaches such as - constraint-induced movement therapy (CIMT) and hand-arm bimanual intensive training (HABIT) of the control group but from a vertical surface
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer, Department of Physical Therapy for Pediatrics and Pediatric Surgery, Faculty of Physical Therapy, Badr University in Cairo, Egypt.

Study Record Dates

First Submitted

October 24, 2022

First Posted

October 27, 2022

Study Start

October 30, 2022

Primary Completion

January 17, 2023

Study Completion

February 28, 2023

Last Updated

April 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

individual participant data is a private data for this research

Locations