NCT07653529

Brief Summary

This study aims to investigate the effect of locomotor training using an antigravity treadmill on cardiorespiratory fitness and lower limb function in patients with incomplete spinal cord injury.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 Progress3%
Jun 2026Dec 2026

First Submitted

Initial submission to the registry

May 20, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

May 20, 2026

Last Update Submit

June 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cardiorespiratory fitness

    Cardiopulmonary fitness will be measured by Cardiopulmonary Exercise Testing (CPET) to assess the integrated function of the cardiovascular, pulmonary, and muscular systems during exercise. The gold-standard parameter obtained from CPET is: VO₂max VO₂max: Maximum rate of oxygen consumption achieved during maximal exercise. Units: mL/kg/min

    At base line and 12 weeks

  • Lower Limb Function

    Lower limb function will be measured by 10-Meter Walk Test (10MWT) is a simple and reliable measure of walking speed, Assesses: Gait speed Procedure Mark a 10-meter walkway. The patient will walks at: Comfortable/self-selected speed (usual gait speed) Walking Speed (m/s)= Distance (m) /Time (s)

    At base line and 12 weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Antigravity Treadmill Training: Participants will undergo locomotor training for 30-45 minutes per session, three sessions per week, for 12 weeks. The training protocol will include: * Warm-up for 5-10 minutes * Walking training with partial body-weight support * Progressive increase in treadmill speed according to tolerance * Gradual reduction of body-weight support * Cool-down period for 5 minutes

Device: Antigravity Treadmill for gait trainingOther: gait training and balance exercise

Control group

ACTIVE COMPARATOR

Thirty patients with incomplete spinal cord injury will receive gait training between parallel bar and balance exercise

Other: gait training and balance exercise

Interventions

Antigravity treadmill for gait training

Study Group

gait training between Parallel bar Balance Exercise

Control groupStudy Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Incomplete spinal cord injury (ASIA C or D)
  • Injury duration more than 3 months
  • Ability to stand with or without assistance
  • Medically stable condition

You may not qualify if:

  • Complete spinal cord injury
  • Severe cardiopulmonary disorders
  • Severe osteoporosis or fractures
  • Severe cognitive impairment
  • Other neurological disorders affecting gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Saher Lotfy Elgayar, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy

Study Record Dates

First Submitted

May 20, 2026

First Posted

June 17, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

October 12, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share