NCT05493696

Brief Summary

Severe burn injuries are associated with hypermetabolic responses and increased catabolism. These generalized changes lead to a vast loss of muscle mass and cause reduced muscle strength and endurance, limited walking ability, and reduced functional mobility Recently, the antigravity treadmill or lower body positive pressure (LBPP) technology has been developed as a unique system of maintaining a participant's body weight all through treadmill training and developing low-load treadmill walking using a unique treadmill system that allows gaining the benefits of low-load treadmill walking without interrupting with locomotion dynamics

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2022

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

1 month

First QC Date

July 30, 2022

Last Update Submit

August 5, 2022

Conditions

Burns

Keywords

BurnGaitBalanceAntigravity treadmill

Outcome Measures

Primary Outcomes (8)

  • Change in Gait characteristics

    Stride length (cm)

    at baseline and after 12 weeks

  • Change in Gait characteristics

    Step length (cm)

    At baseline and after 12 weeks

  • Change in Gait characteristics

    Velocity (cm/sec)

    At baseline and after 12 weeks

  • Change in Gait characteristics

    Cadence (step/mint)

    At baseline and after 12 weeks

  • Change in Gait characteristics

    Double support time (sec)

    At baseline and after 12 weeks

  • Change in Postural stability indices

    Medio-lateral Stability Index (MLI)

    At baseline and after 12 weeks

  • Change in Postural stability indices

    Antero-posterior Stability Index (API)

    At baseline and after 12 weeks

  • Change in Postural stability indices

    Overall Stability Index (OSI)

    At baseline and after 12 weeks

Study Arms (2)

Group 1 (ALG+TPTP)

EXPERIMENTAL

Patients received Antigravity treadmill training + Traditional physical therapy program

Device: Antigravity treadmillOther: Traditional physical therapy program

Group 2 (TPTP)

ACTIVE COMPARATOR

Patients received a Traditional physical therapy program

Other: Traditional physical therapy program

Interventions

Antigravity treadmillDEVICE

Alter G training for 30-minute, 3 times/week, 75% body weight

Also known as: Traditional physical therapy program
Group 1 (ALG+TPTP)
Traditional physical therapy programOTHER

applied 3 times/week for 12 weeks

Group 1 (ALG+TPTP)Group 2 (TPTP)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with circumferential lower limb deep second to third-degree thermal injury
  • Burns extending from the lower trunk to the foot were considered
  • The total body surface area (TBSA) ranges from 35 to 50%
  • All patients completed the same physical therapy program during hospitalization peroid

You may not qualify if:

  • Lower limb prosthesis
  • Severe musculoskeletal disorders
  • Serious cardiovascular insult
  • Participation in an outside physical training program
  • Fracture
  • Medication that negatively impacts the study's results
  • Brain injury
  • Vestibular disorders
  • Visual disorders
  • History of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Applied Medical Sciences

Mecca, 715, Saudi Arabia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Anwar Ebid, PhD

    Professor Physical Therapy

    PRINCIPAL INVESTIGATOR

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
Professor Physical Therapy, Faculty of Applied Medical Sciences

Study Record Dates

First Submitted

July 30, 2022

First Posted

August 9, 2022

Study Start

June 15, 2022

Primary Completion

July 15, 2022

Study Completion

July 28, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)