NCT07633249

Brief Summary

This study aims to investigate the effect of core stability training on trunk control and sitting balance in patients with paraplegia resulting from incomplete spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

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

Study Start

First participant enrolled

November 30, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Weight Distribution Symmetry (Wii Balance Board)

    Assessment of sitting weight-bearing symmetry using the Wii Balance Board by measuring the percentage of body weight distributed between the right and left sides.

    Baseline and after 8 weeks

  • Trunk Impairment Scale (TIS)

    Assessment of trunk control through evaluation of static sitting balance, dynamic sitting balance, and trunk coordination. Higher scores indicate better trunk performance.

    Baseline and after 8 weeks

  • Seated Functional Reach Test (SFRT)

    Assessment of dynamic sitting balance by measuring maximum forward reaching distance while maintaining sitting stability.

    Baseline and after 8 weeks

  • T-shirt Test

    Functional assessment of dynamic sitting balance and trunk coordination through timed dressing performance while seated.

    Baseline and after 8 weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Participants received selected conventional physical therapy program.

Other: selected conventional physical therapy program

Study Group

EXPERIMENTAL

Participants received the same selected conventional physical therapy program in addition to Core Stability Training.

Other: selected conventional physical therapy programOther: conventional physical therapy program in addition to Core Stability Training.

Interventions

Patients received selected conventional physical therapy program in form of: 1. Passive and active-assisted ROM exercises for lower limbs 2. Upper limb strengthening exercises 3. Conventional trunk training on stable sitting surfaces 4. Functional sitting balance exercises 5. Transfer and wheelchair mobility training Treatment was conducted for about 60 minutes, three sessions per week for eight weeks

Control GroupStudy Group

The core stability program consisted of progressive trunk stabilization exercises targeting deep trunk muscles. Training included: 1. Static trunk stabilization exercises 2. Multidirectional reaching tasks 3. Anterior, posterior, and lateral weight-shifting activities 4. Advanced exercises on unstable surfaces 5. Upper limb activities combined with trunk stabilization The sessions were divided into 40-45 minutes of selected conventional physical therapy modalities and exercises, followed immediately by 15-20 minutes of progressive Core Stability Training (CST) targeting the deep stabilizing muscles of the trunk .

Study Group

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with traumatic incomplete SCI.
  • Neurological level between T6 and T12 according to ASIA classification.
  • Age from 25 to 35 years.
  • Ability to maintain unsupported sitting.
  • Medically stable condition.
  • Adequate cognitive ability to follow instructions.
  • Duration of injury more than six months.
  • Moderate trunk impairment (TIS score 8-14).
  • BMI less than 30 kg/m

You may not qualify if:

  • other neurological disorders affecting balance.
  • Uncontrolled cardiovascular conditions.
  • Active lumbar or pelvic pressure sores.
  • Orthopedic disorders affecting trunk control or sitting balance.
  • Severe spasticity interfering with sitting balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy Cairo University

Giza, Giza Governorate, 12613, Egypt

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Mohamed A Fathy, BSc

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 8, 2026

Study Start

November 30, 2025

Primary Completion

March 14, 2026

Study Completion

March 29, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Locations