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

Qassim University

Status: Completed

Conditions: Stroke

Treatments: Device: Anti-Gravity Treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT04767334

20-05-04

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Gait training on Lower body positive pressure

Experimental group

Description:

All participants will have gait training for 40 minutes a day, for three days a week, for six weeks. On session one, the lower body positive pressure chamber will be set to unload 50% of patient's body weight.On the following sessions, the percentage of unload patient's body weight will be decrease depends on the patient's comfort. The physical therapist assistance and treadmill speed will be evaluated and altered based on the patient's capacity. The participants can take a rest whenever his/her need during walking. The rest time will be measured and documented.

Treatment:

Device: Anti-Gravity Treadmill