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

NCT04767334 | Completed FDA Device

• 1 other identifier: 20-05-04
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Participation's safety questionnaire as assessed by numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied).

  The safety of the LBPP will be evaluated by the participation's safety questionnaire. The safety will be measured using numerical rating scale rating from 0 (extremely dissatisfied) - 5 (extremely satisfied). The participant will be asked to rate his/her level of satisfaction for safety variable at the end of 6th weeks.

  Report the safety at 6 weeks

• 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).

  The feasibility of the LBPP will be evaluated by the 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). The participant will be asked to rate his/her level of satisfaction for each variable at the end of 6th weeks.

  Report the feasibility at 6 weeks

• Number of participants who have adverse event as assessed by CTCAE v4.0

  Reporting the presence (or absence) of adverse events

  Through study completion, an average of 1 year.

• Number of sessions

  Reporting the number of sessions for each participant.

  Through study completion, an average of 1 year.

• Number of device limitation as assessed by Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

  Reporting any device limitation that appear during the study

  Through study completion, an average of 1 year.

Secondary Outcomes (3)

• gait function as assessed by 10MWT

  Change from baseline gait at 6 weeks.

• Balance function

  Change from baseline balance at 6 weeks.

• Quality of life as assessed by (Short Form 36)

  Change from baseline quality of life at 6 weeks.

Study Arms (1)

Gait training on Lower body positive pressure

EXPERIMENTAL

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.

Device: Anti-Gravity Treadmill

Interventions

Anti-Gravity Treadmill 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.

Gait training on Lower body positive pressure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Qassim University: lead

Study Sites (1)

Medical City in Qassim University

Buraidah, Saudi Arabia

Location

Related Publications (1)

• 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.

  PMID: 36831709 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 23, 2021
• Study Start: June 2, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)