Clinical trial NCT04767334: The Effect of Lower Body Positive Pressure Treadmill Training on Individuals With Chronic Stroke
Official title: The Effect of Lower Body Positive Pressure Treadmill Training on Postural Control and Gait Function in Individuals With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Hemiparesis due to stroke; at least 6 months since the stroke.
* Independent ambulatory ability with or without assistive device at least 10 meters.
* Do not have any additional neurological and/or orthopedic deficiencies impairing ambulation.
* Functional ambulation ≥ 3 on functional ambulation categories
* No history of cardiac, respiratory, cardiovascular conditions interferes with protocol,
* Able to understand simple instructions,
* Able to control the head and trunk posture.

Exclusion Criteria:

* recurrent stroke,
* spasticity greater than 3 on modified Ashowrth scale,
* Ataxia, or tremor of lower limb

Primary outcomes:
measure: Participation's safety questionnaire as assessed by numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied).
timeFrame: Report the safety at 6 weeks
measure: Participation's satisfaction questionnaire include (comfort, dimensions, personal acceptance, and simplicity of use) will be measured using numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied).
timeFrame: Report the feasibility at 6 weeks
measure: Number of participants who have adverse event as assessed by CTCAE v4.0
timeFrame: Through study completion, an average of 1 year.
measure: Number of sessions
timeFrame: Through study completion, an average of 1 year.
measure: Number of device limitation as assessed by Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: gait function as assessed by 10MWT
timeFrame: Change from baseline gait at 6 weeks.
measure: Balance function
timeFrame: Change from baseline balance at 6 weeks.
measure: Quality of life as assessed by (Short Form 36)
timeFrame: Change from baseline quality of life at 6 weeks.
Other outcomes:
Locations:
city: Buraidah
country: Saudi Arabia
facility: Medical City in Qassim University
Study officials:
References: