NCT04767334

The Effect of Lower Body Positive Pressure Treadmill Training on Individuals With Chronic Stroke

Completed NA Last updated 18 October 2022

What this trial tests

NA trial testing Anti-Gravity Treadmill in Stroke in 9 participants. Completed in 1 October 2022.

Timeline

2 June 2021

Primary endpoint
1 October 2022

1 October 2022

Quick facts

Lead sponsor	Qassim University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	2 June 2021
Primary completion	1 October 2022
Estimated completion	1 October 2022
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Anti-Gravity Treadmill

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Qassim University

Who can join

Adults 18 to 70, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stroke is neurological disease characterized by chronic major disability which will cause permanent changes in individuals life. In Saudi Arabia stroke considered as the main leading of disability and death. It is estimated to be 0.67% in Saudi Arabia compared to 2.5% of the population in the United States (US). Most of individuals have mobility deficit such as walk speed and postural maintenance which lead to increase the risk of fall and decrease activity of daily living (ADL).

Stroke rehabilitation should starts as early as possible to avoid post-stroke complications. Several interventions for stroke rehabilitation to improve mobility deficit and posture control continuously being evaluated. One of the ways of stroke rehabilitation is a using of body weight supported treadmill training (BWSTT). It is a useful tool to facilitate gait training and recovery after neurological injures.

The lower body positive pressure (LBPP) is a treadmill that is enclosed in inflated bag. There is a chamber inside the treadmill that is produce air pressure which is aid in eliminate the uncomfortableness feeling produce by weight bearing during gait. The chamber is supplied with a system provide LBPP aiding in decrease patient weight while walking by giving the patient lifting force from below using air pressure. This helps the patient to walk affectively with minimum weight bearing on the lower extremity.

Therefore, the purpose of the study is to evaluate the feasibility and effectiveness of LBPP on gait function, balance and quality of life in chronic stroke individuals.

The investigators hypothesis that the LBPP will significantly improve gait function, balance, quality of life in chronic stroke patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Safety and Feasibility of Lower Body Positive Pressure Treadmill Training in Individuals with Chronic Stroke: An Exploratory Study.
   Almutairi SM, Alfouzan MM, Almutairi TS, Alkaabi HA, et al · · 2023 · cited 1× · PMID 36831709 · DOI 10.3390/brainsci13020166