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Chronic StrokeNCT04673045

Effects of Neuromuscular Electrical Stimulation on Individuals With Chronic Stroke in Patients With Chronic Stroke

A study testing Active Electrical stimulation in people with Chronic Stroke, run by Qassim University at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Stroke is commonly associated with increased spasticity that affects patients' function and increased risk of fall. Interventional approaches have been used to decrease spasticity including pharmacological and non-pharmacological interventions. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Stroke
What is being tested?
Active Electrical stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSaudi Arabia
Study dates
2 Feb 2021to Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hemiparesis due to stroke; at least 6 months since stroke
  • Independent ambulatory ability with or without assistive device at least 10 meters
  • Spasticity on ankle dorsiflexors ≥ 2 on Modified Ashworth Scale (MAS) (Charalambous, 2014)
  • Functional ambulation ≥ 3 on functional ambulation categories (Mehrholz, Wagner, Rutte, Meiβner, \& Pohl, 2007)

Who cannot join

  • Skin integrity issues on contact surface of NMES
  • Significant cognitive impairments (unable to follow 3 step commands),
  • Other serious medical conditions
  • History of other neurologic or orthopedic disorder affecting walking function
  • More than one previous stroke
  • Contraindications to NMES, such as a pacemaker or tumor
  • Injected with any medicine that reduce spasticity

Trial locations and contacts

1 site in 1 country.

Sattam Almutairi, Ph.D contact

966505102644

A.Sattam@qu.edu.sa

Saudi Arabia1 site, 1 recruiting

  • King Fahad Specialist Hospital

    Buraidah

    Sattam Almutairi, 0505102644

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Effects of Neuromuscular Electrical Stimulation on Walking Ability and Quality of Life in Individuals With Chronic Stroke

Stroke is commonly associated with increased spasticity that affects patients' function and increased risk of fall. Interventional approaches have been used to decrease spasticity including pharmacological and non-pharmacological interventions. However, Limited research has examined non-pharmacological interventions such as neuromuscular electric stimulation (NMES) on spasticity and health outcomes in people with stroke. So, The primary purpose of this study is to establish a protocol for a randomized clinical trial to examine using NMES on spasticity, muscle strength, physical functions, and self-reported health outcomes in people with chronic stroke in Saudi Arabia.

This randomized clinical trial will be double blinded for both participants and assessors to enroll 40 participants with chronic stroke to either interventional group or control shame group. The intervention will be 3 times a week for 4 weeks for both groups. Outcomes will include calf muscle spasticity, pretibial muscle strength, ankle range of motion, gait speed, balance, functional mobility, walking endurance, and self-reported health measures such as quality of life, physical activity, fatigue, and risk of fall. Independent t-test will be utilized to examine the effect of intervention on change score means for outcome measures. Using 4 weeks of NMES will provide information about its effect in improving spasticity, physical functions, and other self-reported health outcomes in people with chronic stroke when compared to control shame NMES.

We assume this electrical stimulation will reduce leg muscle spasticity and improve muscle strength. Therefore, this study will help individuals with chronic stoke in improve walking function, balance, and quality of life.

Read the detailed description

Assignment of intervention:

Allocation sequence generation: The participants will be randomly allocated to either a EG or a NMESsham. The randomization process will be generated by an independent research assistant who is not involved in the treatment or data collection using online randomization website (https://www.graphpad.com/quickcalcs/randomize1.cfm).

Allocation concealment: All randomized allocations of participants will be placed in a sealed envelope for each participant. A research assistant will prepare envelopes and withholds information from assessors and participants. After completing the baseline assessment, a research assistant will inform the training therapist who is not involved in the study about the patients' allocation.

Blinding: In this double-blind study, the assessors and patients will be blinded to groups' allocation. Assessors will be banned from attending interventional sessions for both groups, and participant's allocation will be managed in schedules to minimize contact between participants in both groups.

After the inform consent, participants will complete an intake form or demographic data (age, sex, occupation), past medical history, past surgical history and activity level. Additionally, they will be screened for inclusion/exclusion criteria. Participants who meet the inclusion/exclusion criteria will be evaluated on the main outcomes prior and post to the intervention. The participants will be randomized into 2 groups.

All participants will receive conventional rehabilitation program (CRP) including warming up, strengthening, stretching exercise, gait training for 45 minutes per a day for three times a week for four weeks. In addition, EG will receive 30 minutes active NMES and the control group will receive 30 minutes NMESSham. The NMES delivered the electrical current through electrodes inserted in saline-soaked sponges. The intensity of stimulation will be set within the subject's tolerance level. The amplitude was adjusted to produce muscle contraction without affecting the patient's comfort. The cathode electrode will be placed over the common peroneal nerve as it passes over the head of the fibula and the anode will be placed on mid-muscle belly on one third of the line between fibular head and medial malleolus on paretic limb. For NMESsham group, electrode sponges will be placed at the same position as the active NMES condition; however, the current intensity will gradually decreased after few seconds to 0. Therefore, the participant will experience a passage of current on the muscle at the beginning but received no current for the rest of the stimulation period. The participants will be informed that the stimulation below the sensory level.

The pre- and post-training assessments will be completed within 3 days before and after the training sessions. Assessment data will be obtained by another physical therapist who blind to the group assignment.

Conditions
Chronic Stroke
Being tested
Active Electrical stimulation, Sham Electrical Stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Electrical stimulationDevice

    Also called GymnaUniphy NV / COMBI 400

    The intensity of stimulation will be set within the subject's tolerance level. The amplitude was adjusted to produce muscle contraction without affecting the patient's comfort. The cathode electrode will be placed over the common peroneal nerve as it passes over the head of the fibula and the anode will be placed on mid-muscle belly on one third of the line between fibular head and medial malleolus on paretic limb.

  • Sham Electrical StimulationDevice

    Also called GymnaUniphy NV / COMBI 400

    For sham group, the current intensity will gradually decreased after few seconds to 0. Therefore, the participant will experience a passage of current on the muscle at the beginning but received no current for the rest of the stimulation period. The participants will be informed that the stimulation below the sensory level.

Study groups in NCT04673045
Study groupRoleWhat they receive
Active neuromuscular electrical stimulationActive comparatorThis group will receive active NMES delivered the electrical current through electrodes inserted in saline-soaked sponges.
Receives: Device: Active Electrical stimulation
Sham neuromuscular electrical stimulationSham comparatorThis group will receive sham NMES
Receives: Device: Sham Electrical Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Modified Ashworth Scale (MAS) at baseline and 4 weeks

    The spastic plantarflexor muscles tone will be measured on affected leg by using MAS. Spasticity will be graded according to MAS which is a 6-point rating scale with scores ranging from 0 (No increase in muscle tone) to 4 (Affected part(s) rigid in flexion or extension) for ankle dorsiflexor (Charalambous, 2014). Participants will be placed in a supine position. To test ankle plantarflexor muscles' spasticity, from maximal ankle plantarflexor position, passively move the ankle to maximal dorsiflexion position over one second. The test will be performed at the baseline and post the intervention.

    Measured: Change from baseline spastic plantarflexor muscles tone in affected leg at 4 weeks.

  2. Active and Passive Range of Motion at baseline and 4 weeks

    The evaluation tests consisted of passive and active ankle joint ROM. The measurement will be in degrees using a handheld goniometer. Goniometry was performed with the subject in supine position with extended knees, and the measurement was made at the neutral position between dorsal flexion and plantar flexion. The axis of the goniometer will be placed 2 cm below the medial malleolus, and its moving axis will be placed along the first metatarsal bone. The passive ROM was determined as the range that the experimenter was able to move the subject's ankle beginning in maximum plantarflexion, to maximum dorsiflexion until any resistance was felt. Similarly the active ROM was measured by asking the participants to move joints maximally. The test will be performed at the baseline and post the intervention. The average of three measurements will be calculated and the result will be the dorsiflexion ROM.

    Measured: Change from baseline of active and passive range of motion in affected ankle joint at 4 weeks.

  3. Manual Muscle Test for Ankle Dorsiflexors at baseline and 4 weeks

    Ankle dorsiflexion is an important kinematic aspect of the swing and initial stance phase of the gait cycle. In clinical practice, muscle strength is most often evaluated using manual muscle strength testing using the Medical Research Council (MRC) grade. The ankle dorsiflexor strength will be graded according to the MMT; graded from 0 (no contraction at all) to 5 (full range of movement against power and the same force as on the opposite side) for ankle dorsiflexor. The test will be performed at the baseline and post the intervention.

    Measured: Change from baseline ankle dorsiflexors in affected leg at 4 weeks.

  4. 10-Meter Walk Test (10MWT) at baseline and 4 weeks

    The 10MWT assesses self-selected preferred walking speed over a short duration with or without an assistive device. The participant will be asked to walk a total of 10 meters where an acceleration zone is used for the participants to accelerate 2 meters before entering the 6-meter distance and 2 meters to decelerate afterwards. Speed is only calculated for the 6m distance between the end zones. The 10MWT is widely used in clinical practice and in research for people with stroke and has been shown to have an excellent test-retest reliability (ICC > 0.95) (Collen, Wade, \& Bradshaw, 1990). The minimally clinically important difference (MCID) is reported as 0.14 m/s for substantial meaningful change (Perera, Mody, Woodman, \& Studenski, 2006). The test will be performed three times and the resulting speeds obtained will be averaged. The test will be performed at the baseline and post the intervention.

    Measured: Change from baseline gait velocity at 4 weeks.

  5. Timed Up and Go at baseline and 4 weeks

    Timed Up-and-Go (TUG) test will be used to measure the walking time. The TUG assesses functional mobility by assessing an individual's ability to stand up, walk 3 meters at a comfortable pace, turn 180 degrees, walk 3 meters, and sit down (Shumway-Cook, Brauer, \& Woollacott, 2000). The TUG test has been shown the excellent reliability and validity in stroke population and the minimal detectable change (MDC) is 2.9 seconds (Flansbjer, Holmback, Downham, Patten, \& Lexell, 2005). Two practice trials of the TUG will be allowed to familiarize the participant with the task. TUG is a valid method for screening of functional mobility and risk for falls in community-dwelling elderly people(Shumway-Cook et al., 2000).

    Measured: Change from baseline mobility at 4 weeks.

Secondary outcomes (7)

  1. Fall Efficacy Scale International (FES-I) at baseline and 4 weeks

    Risk of fall will be measured using Fall Efficacy Scale-International (Yardley et al., 2005). It is a 16-items self-reported measuring fear of falling in older adults and people with chronic conditions. Each item involves an activity that will be score by the participant using 4-point Likert scale depending on how concerned to fall if they did this activity regardless of actual performance. The scores range from 16 to 64, with higher scores indicate a high risk of fall. This scale has been translated and validated into Arabic language (Halaweh, Svantesson, Rosberg, \& Willen, 2016).

    Measured: Change from baseline balance at 4 weeks.

  2. Rapid Assessment of Physical Activity (RAPA) at baseline and 4 weeks

    It is a 9-item, self report questionnaire measures the levels of physical activity of adult older than 50 years. The response to each item is yes or no. The instructions for completing the questionnaire provide a brief description of three levels of physical activity (light, moderate, and vigorous) with graphic and text depictions of the types of activities that fall into each category. The total score of the first seven items is from 1 to 7 points, with the respondent's score categorized into one of five levels of physical activity: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active. Responses to the strength training and flexibility items are scored separately, with strength training = 1, flexibility = 2, or both = 3 (Topolski et al., 2006). This measure has been cross-culturally adapted and validated to Arabic language (Alqahtani \& Alenazi, 2019).

    Measured: Change from baseline physical activity at 4 weeks.

  3. Patient Health Questionnaire-9 at baseline and 4 weeks

    it is a good instrument to evaluate depression symptoms among different populations. It has 9 items, and each item uses a Likert scale of 4 options ranging from 0 (not at all) to 3 (nearly every day). A total score of 27 indicates severe depression, and a cut off score of 10 has been used to diagnose moderate depression (Kroenke, Spitzer, \& Williams, 2001; Kroenke \& Spitzer, 2002; Kroenke, Spitzer, \& Williams, 2003). Previous research has found that this is a reliable and valid instrument for different populations including people with stroke (Janneke et al., 2012). This instrument has been translated and validated into different languages including Arabic (AlHadi et al., 2017; Becker, Al Zaid, \& Al Faris, 2002).

    Measured: Change from baseline depression at 4 weeks.

  4. Fatigue Severity Scale (FSS) at baseline and 4 weeks

    It is a self-reported questionnaire that consists of 9 statements that rate the severity of the patient's fatigue interferes with certain activities. The items are scored from 1 to 7 with 1 = strongly disagree and 7 = strongly agree. The minimum score = 9 and maximum score possible = 63. The higher score indicate greater fatigue severity (Krupp, LaRocca, Muir-Nash, \& Steinberg, 1989). The mean score of the 9 items will be used for statistical analysis. The FSS has been shown to have high internal consistency, good test-retest reliability, and good concurrent validity in several population (Hagell et al., 2006; Learmonth et al., 2013; Lerdal \& Kottorp, 2011). This scale has been translated and validated into Arabic language (Al-Sobayel et al., 2016).

    Measured: Change from baseline fatigue at 4 weeks.

  5. Quality of life (Short Form 36) at baseline and 4 weeks

    It is a survey that evaluates the quality of life in clinical practice and research purpose. It has 8 dimensional subscales: physical functioning, role limitations due to physical problems, general health perceptions, vitality, social functioning, role limitations due to emotional problems, general mental health, and health transition. Short form-36 has been translated and validated into Arabic language (Coons, Alabdulmohsin, Draugalis, \& Hays, 1998; Sabbah, Drouby, Sabbah, Retel-Rude, \& Mercier, 2003).

    Measured: Change from baseline quality of life at 4 weeks.

  6. Six Minute Walk Test at baseline and 4 weeks

    It assesses the distance walked over 6 minutes as a test of aerobic capacity and endurance. In this test, the patient can has standing rest as many as they like, but the timer should keep recording and the number of rests taken should taken and the total rest time. Also, the patient can use any assistive device but needs to be documented. Only minimum amount of assistance is accepted if the patient needs and the level of the assistance should be documented. The examiner should walk behind the patient at least half step when the patient administrating the test. The American thoracic society guidelines recommend use of a 30 meter with the length of the corridor marked every 3 meters. Turnaround points are to be marked by a cone. The participants will be asked to eat a light meal and wear comfortable clothes and shoes. Participants will be informed every minute elapsed. The heart rate, blood pressure, and oxygen saturation will be taken before and at the end of the test. The 6MWT will be

    Measured: Change from baseline endurance at 4 weeks.

  7. The Barthel index (BI) at baseline and 4 weeks

    It contains 10 common activities of daily living (ADL) to assess disability (Wade, 1992). It includes: feeding, grooming, bathing, dressing, bowel and bladder care, toilet use, ambulation, transfers, and stair climbing. The scale yields to a total score out of 100. The higher the score, the greater the degree of functional independence. The minimal clinically important differences (MCID) is 1.85 in stroke population (Hsieh et al., 2007). The BI has demonstrated useful instrument with high inter-rater reliability, internal consistency, convergent and predictive validity, and adequate responsiveness in stroke patients (Hsueh, Lee, \& Hsieh, 2001). Each patient's ADL performance will be rated primarily by interviewing the patients, their primary caregiver, or their nurse. Observation of performance will be applied if necessary.

    Measured: Change from baseline activities of daily living at 4 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2020
  2. Study start2 Feb 2021
  3. Primary completionJun 2023 (estimated)
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04673045
Sponsor's protocol ID
10126-fcohsb-2020-1-3-I
Status last verified
Sep 2022
First submitted
7 Dec 2020
Last updated
13 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alahmari, K., & Paul, S. (2016). Prevalence of stroke in kingdom of saudi arabia-through a physiotherapist diary. Mediterranean Journal of Social Sciences, 7(1 S1), 228.

  • AlHadi AN, AlAteeq DA, Al-Sharif E, Bawazeer HM, Alanazi H, AlShomrani AT, Shuqdar RM, AlOwaybil R. An arabic translation, reliability, and validation of Patient Health Questionnaire in a Saudi sample. Ann Gen Psychiatry. 2017 Sep 6;16:32. doi: 10.1186/s12991-017-0155-1. eCollection 2017.

    PubMed 28878812

  • Alqahtani, B. A., & Alenazi, A. M. (2019). Cross-cultural adaptation and validation of the arabic version of the rapid assessment of physical activity: 1372: Board# 134 may 30 9: 30 AM-11: 00 AM. Medicine & Science in Sports & Exercise, 51(6), 368.

  • Alqahtani BA, Alenazi AM, Hoover JC, Alshehri MM, Alghamdi MS, Osailan AM, Khunti K. Incidence of stroke among Saudi population: a systematic review and meta-analysis. Neurol Sci. 2020 Nov;41(11):3099-3104. doi: 10.1007/s10072-020-04520-4. Epub 2020 Jun 20.

    PubMed 32564272

  • Al-Sobayel HI, Al-Hugail HA, AlSaif RM, Albawardi NM, Alnahdi AH, Daif AM, Al-Arfaj HF. Validation of an Arabic version of Fatigue Severity Scale. Saudi Med J. 2016 Jan;37(1):73-8. doi: 10.15537/smj.2016.1.13055.

    PubMed 26739978

  • Barbeau, H., Pépin, A., Norman, K. E., Ladouceur, M., & Leroux, A. (1998). Walking after spinal cord injury: Control and recovery. The Neuroscientist, 4(1), 14-24.

  • Becker S, Al Zaid K, Al Faris E. Screening for somatization and depression in Saudi Arabia: a validation study of the PHQ in primary care. Int J Psychiatry Med. 2002;32(3):271-83. doi: 10.2190/XTDD-8L18-P9E0-JYRV.

    PubMed 12489702

  • Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

    PubMed 30700139

  • Charalambous, C. P. (2014). Interrater reliability of a modified ashworth scale of muscle spasticity. Classic papers in orthopaedics (pp. 415-417) Springer.

  • Collen FM, Wade DT, Bradshaw CM. Mobility after stroke: reliability of measures of impairment and disability. Int Disabil Stud. 1990 Jan-Mar;12(1):6-9. doi: 10.3109/03790799009166594.

    PubMed 2211468

  • Coons SJ, Alabdulmohsin SA, Draugalis JR, Hays RD. Reliability of an Arabic version of the RAND-36 Health Survey and its equivalence to the US-English version. Med Care. 1998 Mar;36(3):428-32. doi: 10.1097/00005650-199803000-00018.

    PubMed 9520966

  • Daneski K, Coshall C, Tilling K, Wolfe CD. Reliability and validity of a postal version of the Reintegration to Normal Living Index, modified for use with stroke patients. Clin Rehabil. 2003 Dec;17(8):835-9. doi: 10.1191/0269215503cr686oa.

    PubMed 14682554

  • Demetrios M, Khan F, Turner-Stokes L, Brand C, McSweeney S. Multidisciplinary rehabilitation following botulinum toxin and other focal intramuscular treatment for post-stroke spasticity. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009689. doi: 10.1002/14651858.CD009689.pub2.

    PubMed 23740539

  • Dorsch S, Ada L, Canning CG, Al-Zharani M, Dean C. The strength of the ankle dorsiflexors has a significant contribution to walking speed in people who can walk independently after stroke: an observational study. Arch Phys Med Rehabil. 2012 Jun;93(6):1072-6. doi: 10.1016/j.apmr.2012.01.005. Epub 2012 Mar 29.

    PubMed 22464738

  • Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.

    PubMed 15788341

Questions about this trial

What is this clinical trial studying?

A study testing Active Electrical stimulation in people with Chronic Stroke, run by Qassim University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sattam Almutairi, Ph.D (966505102644, A.Sattam@qu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Ashworth Scale (MAS) at baseline and 4 weeks (time frame: Change from baseline spastic plantarflexor muscles tone in affected leg at 4 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04673045, which also lists 50 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.

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