Does Isolated Robotic-Assisted Gait Training Improve Functional Status, Daily Living And Quality Of Life In Stroke?

NCT02759627 | Completed

• 1 other identifier: A-22
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

Stroke is one of the major cause of morbidity and mortality and the leading cause of disability in adults all around the world. Stroke survivors can suffer several neurological impairments and deficits which have an important impact on patient's quality of life and which increase the costs for health and social services. After stroke, impairments in ADLs and functional status, deterioration in health related quality of life can be seen. Although most of the stroke survivors experience some level of neurological recovery, nearly 50%-60% of stroke patients still experience some degree of motor impairment, and approximately 50% are at least partly dependent in activities-of-daily-living (ADL). Gait recovery, performing activities of daily living and regaining independence in ADLs are the main focus of stroke rehabilitation programs. Robotic technologies are becoming more promising techniques for the locomotor training in stroke patients. Achieving a functional walking level is one of the target of robotic gait training and it has been shown that Robotic-Assisted Gait Training (RAGT) improves walking function in stroke patients. Having a functional gait level may help the stroke patients to regain independence in ADLs and improve quality of life. The purpose of the present study was to investigate the effects of RAGT on functional status, ADLs and health related quality of life.

Conditions

Cerebrovascular Stroke; Cerebrovascular Accident; Cerebral Stroke

Keywords

Rehabilitation; Gait; Ambulation; Exercise Therapy; Physical Exertion; Motor Skills

Outcome Measures

Primary Outcomes (4)

• The Barthel Index (BI)

  The BI was used to determine the level of independence in functional activities and included ten items. The score ranges from 0-100, and a higher BI score indicates better functioning. Minimal clinically important difference for BI is 18.5 points.

  6 weeks

• The Stroke Specific Quality of Life Scale (SSQOL).

  The Stroke Specific Quality of Life scale (SS-QOL) was used to address the ICF participation component.The score for the questionnaire is between 26 (lowest social participation) and 130 (highest social participation).

  6 weeks

• The 6-Minute Walk Test (6MWT)

  Walking function was assessed by distance walked in 6 minutes (6MWT).Usual ambulatory devices, lower-extremity orthotics, and stand-by assistance were permitted. Therapists closely guarded participants during gait testing, but did not provide physical assistance. For the 6-minute walk test, participants walked through continuous hallways with minimal foot traffic. End of the test walked distance recorded by meter.

  6 weeks

• The Stair Climbing ascend and descend tests (SCas and SCde)

  Participants climbed up and down 10 steps (measuring 18 cm in height), with or without the use of the rails and/or assistive devices. Subjects were asked to climb the stairs without skipping any steps, preferably using one foot for each step and descend without stopping. The time taken to climb up and down the 10 steps was recorded as a second.

  6 weeks

Secondary Outcomes (4)

• The Fugl-Meyer Assessment (FMA)

  6 weeks

• The Comfortable 10-m Walk Test (CWT)

  6 weeks

• Rate of Perceived Exertion (RPE)

  6 weeks

• The Fast 10-m Walk Test (FWT)

  6 weeks

Study Arms (3)

Conventional Training

NO INTERVENTION

Conventional physical therapy consisted of neurophysiological concepts such as Bobath and Brunnstrom.Training sessions focused on static and dynamic postural tasks, improving lower and upper extremity range of motion, strengthening and overground walking. During walking training, emphasis was on distance walked than on gait quality. Symmetrical weight distribution was encouraged through verbal and tactile cues and was made more difficult by the addition of arm activities or actions requiring trunk rotation. In an effort to improve rhythmic weight-shifting ability, subjects practiced shifting their weight in forward and backward directions and side to side while performing reaching tasks. A session lasted 45 minutes, for 5 days per week for 6 weeks.

Robotic-Assisted Gait Training

EXPERIMENTAL

Lokomat (Hocoma) was used in Robotic-Assisted Gait Training group with 20 % body weight reduced. The participants walked on device at 1.8 km/h (0.5 m/sec) velocity. For each participant body weight portion was ensured by a security belt while walking. Each session took 45 minutes including setup, commands and rest time. Verbal instructions were used for encouragement but no manual assistance was given to improve gait. Robotic-Assisted Gait Training sessions lasted 45-minute sessions, 2 days a week during 6 weeks.

Other: Robotic-Assisted Gait Training

Combined Training

NO INTERVENTION

Combined Training consisted of inpatient participants who were treated with 45 minute-conventional training, 5 days a week during 6 weeks. Additionally this group had 45 minute-Robotic-Assisted Gait Training, 2 days a week during 6 weeks.

Interventions

Robotic-Assisted Gait Training OTHER

There were three intervention arms in this study, 1. Robotic-Assisted Gait Training, 2. Conventional Training, 3. Combined Training.

Robotic-Assisted Gait Training

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of a stroke (at least 3 months),
• ambulatory with or without the use of an assistive device or ankle-foot orthosis,
• or higher grades in Functional Ambulation Category,
• able to walk 10 meters with or without supervision,
• able to follow verbal instructions,
• physician approval to enter an exercise program.

You may not qualify if:

• previous stroke history,
• any other neurologic disorders, complications from other health conditions (cardiovascular or musculoskeletal conditions),
• contracture or muscle tonus ≥ 3 according to Modified Ashworth Scale, preventing range of motion in lower extremity,
• severe osteoporosis,
• cognitive deficit preventing them from following instructions.

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (14)

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  PMID: 22165907 BACKGROUND

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  PMID: 3629639 BACKGROUND

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• Mao YR, Lo WL, Lin Q, Li L, Xiao X, Raghavan P, Huang DF. The Effect of Body Weight Support Treadmill Training on Gait Recovery, Proximal Lower Limb Motor Pattern, and Balance in Patients with Subacute Stroke. Biomed Res Int. 2015;2015:175719. doi: 10.1155/2015/175719. Epub 2015 Nov 16.

  PMID: 26649295 BACKGROUND

• Borg G. Perceived exertion as an indicator of somatic stress. Scand J Rehabil Med. 1970;2(2):92-8. No abstract available.

  PMID: 5523831 BACKGROUND

• ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

  PMID: 12091180 BACKGROUND

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• Silva SM, Correa FI, Faria CD, Correa JC. Comparison of quality-of-life instruments for assessing the participation after stroke based on the International Classification of Functioning, Disability and Health (ICF). Braz J Phys Ther. 2013 Sep-Oct;17(5):470-8. doi: 10.1590/S1413-35552012005000118. Epub 2013 Oct 21. English, Portuguese.

  PMID: 24173349 BACKGROUND

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  PMID: 25729175 BACKGROUND

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  PMID: 11336098 BACKGROUND

• Visintin M, Barbeau H. The effects of body weight support on the locomotor pattern of spastic paretic patients. Can J Neurol Sci. 1989 Aug;16(3):315-25. doi: 10.1017/s0317167100029152.

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  PMID: 1135616 BACKGROUND

• Hsieh YW, Wang CH, Wu SC, Chen PC, Sheu CF, Hsieh CL. Establishing the minimal clinically important difference of the Barthel Index in stroke patients. Neurorehabil Neural Repair. 2007 May-Jun;21(3):233-8. doi: 10.1177/1545968306294729. Epub 2007 Mar 9.

  PMID: 17351082 BACKGROUND

• Mustafaoglu R, Demir R, Demirci AC, Yigit Z. Effects of core stabilization exercises on pulmonary function, respiratory muscle strength, and functional capacity in adolescents with substance use disorder: Randomized controlled trial. Pediatr Pulmonol. 2019 Jul;54(7):1002-1011. doi: 10.1002/ppul.24330. Epub 2019 Apr 26.

  PMID: 31026384 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• IPEK YELDAN, Assoc.prof

  Istanbul University, Faculty of Health Sciences, Division of Physiotherapy and Rehabilitation Istanbul, Turkey

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc, PT

Study Record Dates

• First Submitted: April 29, 2016
• First Posted: May 3, 2016
• Study Start: November 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 9, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share