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

NCT ID: NCT04767334

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-02
• Study Completion Date: 2022-10-01

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.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gait training on Lower body positive pressure

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.

Group Type: EXPERIMENTAL

Anti-Gravity Treadmill

Intervention Type: DEVICE

Each participant will started with a 5 - 10 minute warm-up on a standard cycle ergometer, manual and therapeutic therapy for upper extremity, and gait training using LBPP. Manual and therapeutic therapy will consist of passive and active ROM, joint mobilization, passive and active stretch, manual resistance exercise, and activities of daily life (ADL). All participants will walk in Alter G one session a day (for 40 min), three days a week, for six weeks. On session one, the Alter G 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.

Interventions

Anti-Gravity Treadmill

Each participant will started with a 5 - 10 minute warm-up on a standard cycle ergometer, manual and therapeutic therapy for upper extremity, and gait training using LBPP. Manual and therapeutic therapy will consist of passive and active ROM, joint mobilization, passive and active stretch, manual resistance exercise, and activities of daily life (ADL). All participants will walk in Alter G one session a day (for 40 min), three days a week, for six weeks. On session one, the Alter G 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qassim University

OTHER

Sponsor Role: lead

Responsible Party

Sattam Almutairi

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical City in Qassim University

Buraidah, , Saudi Arabia

Countries

Saudi Arabia

References

Almutairi SM, Alfouzan MM, Almutairi TS, Alkaabi HA, AlMulaifi MT, Almutairi MK, Alhuthaifi FK, Swank C. The Safety and Feasibility of Lower Body Positive Pressure Treadmill Training in Individuals with Chronic Stroke: An Exploratory Study. Brain Sci. 2023 Jan 18;13(2):166. doi: 10.3390/brainsci13020166.

Reference Type: DERIVED

PMID: 36831709 (View on PubMed)

Other Identifiers

20-05-04

Identifier Type: -

Identifier Source: org_study_id