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AzTrials

Stroke, IschemicNCT05904860

Effects of Backward vs Forward Gait Training With Auditory Feedback in Patients With Stroke

A study testing Backward Gait Training and Forward Gait Training in people with Stroke, Ischemic, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

One of the major expressions of chronic disability in patients with cerebrovascular accidents is in terms of impaired gait and balance. Both of these limitations have an ultimate effect in terms of increased risk of falls leading to augmented morbidity and mortality. Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Stroke, Ischemic
What is being tested?
Backward Gait Training and Forward Gait Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
6 Jun 2023to 25 Jul 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 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both genders First-time ischemic stroke Diagnosed Middle cerebral artery stroke patients Sub-acute stroke 3 weeks- 11 weeks Hemiplegia Age 35 years to 65 years Brunnstorm's stages 4 to 6 Able to maintain standing posture with minimum assistance with a Berg balance scale score greater than 45

Who cannot join

  • GCS lower than 15 Any other neurological diagnosis Presence of associated cognitive impairment Lower extremity joint deformities Any prominent visual problem hindering ambulation Patients with auditory compromise and patients using hearing aids

Trial locations and contacts

1 site in 1 country.

Manan Haider, PhD contact

+923334839810

m_manan.drs@stmu.edu.pk

Syed Ali Hussain, PhD* contact

+923315191713

alihussain_dpt.ahs@stmu.edu.pk

Pakistan1 site, 1 recruiting
  • Shifa Tameer-e-Millat University Islamabad

    Islamabad, Fedral, 44000

    Manan Haider, PhD, +923334839810, m_manan.drs@stmu.edu.pk

    Syed Ali Hussain, PhD*, +923315191713, alihussain_dpt.ahs@stmu.edu.pk

    Recruiting

Other trials in Pakistan

About this study

One of the major expressions of chronic disability in patients with cerebrovascular accidents is in terms of impaired gait and balance. Both of these limitations have an ultimate effect in terms of increased risk of falls leading to augmented morbidity and mortality. Further results of gait abnormalities and balance impairments are increased morbidity with many other manifestations including but not limited to; pain, a significant reduction in quality of life, muscle as well as joint stiffness, postural instability self-imposed restricted physical functioning, and limited social interaction. The chances of an acute recurrent stroke are substantially increased due to restricted mobility.

Read the detailed description

A variety of treatment options are available for balance improvement and gait training in stroke patients including conventional treatment options of stretching, muscle strengthening, limb stabilization joint mobilizations followed by forward walking training with or without support and modern technological advancements including virtual reality immersion exercises, motor imagery and hydro treadmill. However, backward walking, also known as retro gait, is the emerging key therapy for gait training. Neuronal circuits located inside the spinal cord and brainstem; known as central pattern generators (CPGs), are primarily responsible for producing automated outputs for rhythmic motor responses example ambulation. These CPGs, along with the descending system, are responsible for motor neuron activation by setting the threshold muscle lengths. The CPGs that are responsible for forward ambulation, also regulate the backward gait. A more intensified recruitment of lower limb musculature motor unit has been observed during backward gait in individuals. Also, due to the restricted visual field when walking backward, the temporal and spatial gait parameters are significantly increased. For the aforementioned reasons, backward gait training can be used as an alternative strategy to improve balance and ambulation.

The performance of an individual during motor relearning can be influenced by using a stimulus from an external source that will generate a behavioral response leading to self-modification in motor action known as a biofeedback system. The most common types of biofeedback include visual, auditory as well as tactile stimuli that inform the individual involved in biofeedback training, about his relative achievements in reaching gait and balance-related targets. Recent literature proposes the notion that in a comparison of visual biofeedback versus auditory biofeedback, individuals under study are more prone to develop a dependence on external cues when using visual biofeedback. Also, poor performance was demonstrated by individuals receiving training with visual feedback on motor retention tests as compared to the individuals receiving auditory feedback. Thus auditory feedback tends to be more helpful in terms of motor relearning.

Backward walking training activates the central pattern generators that are responsible for ambulation however, muscle fiber recruitment had been observed to be more intensified as compared to recruitment during forward gait training. Forward gait training with auditory biofeedback effectively improves stride length, balance, and walking speed in individuals with stroke.

Since backward gait training has a more pronounced effect on gait parameters as compared to forward walking, also, in the light of recent evidence motor re-learning can be enhanced using biofeedback, the combined effect of backward gait training with auditory biofeedback could produce more pronounced effects in terms of motor recovery and improved balance and decreased risk of fall as compared to conventional forward gait training with biofeedback.

Being tested
Backward Gait Training, Forward Gait Training
Keywords
Stroke, Gait Training, Auditory feedback
Medical subject headings
Ischemic Stroke, Stroke

What participants receive

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

  • Backward Gait TrainingOther

    Also called Auditory Feedback

    Backward gait training will be provided within parallel bars, a mirror, and on a firm surface. The harness belt will be around the patient's torso to avoid sudden falls.

  • Forward Gait TrainingOther

    Also called Auditory Feedback

    Forward gait training will be provided within parallel bars, a mirror, and on a firm surface. The harness belt will be around the patient's torso to avoid sudden falls.

Study groups in NCT05904860
Study groupRoleWhat they receive
Experimental GroupOtherThe experimental group will be receiving a 30-minute backward gait training using parallel bars, a mirror, and on a firm surface. Patients will receive training for 4 days per week with a total time period of 4 weeks. Balance, fall risk, and spatiotemporal gait parameters will be quantified and evaluated before the commencement of treatment, after 2 weeks, and at the end of the last session.
Receives: Other: Backward Gait Training
Control groupOtherThe control group will be receiving a 30-minute forward gait training using parallel bars, a mirror and on a firm surface. Patients will receive training for 4 days per week with a total time period of 4 weeks. Balance, fall risk, and spatiotemporal gait parameters will be quantified and evaluated before the commencement of treatment, after 2 weeks, and at the end of the last session.
Receives: Other: Forward Gait Training

What is being measured

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

  1. Berg Balance Scale

    It is a 14 items static and dynamic balance measurement tool. The total score on this scale is 56 with 4 maximum scores in each item. Higher scores demonstrate good balance. Lower scores demonstrate poor balance.

    Measured: 4 weeks

  2. Cadence

    Pedometers are designed to detect vertical movement at the hip and so measure the number of steps and provide an estimate of the distance walked. They cannot provide information on the temporal pattern of physical activity or the time spent in different activities at different intensities.

    Measured: 4 weeks

  3. Walking Speed

    walking speed that would be calculated using formula "Walking speed = distance covered / time taken

    Measured: 4 weeks

  4. Stride Length

    stride length that would be calculated using formula "Stride length = Distance covered / (1/2x cadence)

    Measured: 4 weeks

  5. Step Length

    step length that would be calculated using formula "Step length = stride length / 2

    Measured: 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 posted15 Jun 2023
  2. Study start6 Jun 2023
  3. Primary completion11 Jul 2023 (estimated)
  4. Study completion25 Jul 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
Model description
total two groups are formed with 22 participants in each group. One is the treatment group which will receive backward gait training. The other is the control group receiving forward gait training. Pre-intervention outcomes are measured. Followed by mid-protocol outcome measurement after 2 weeks and end-protocol measurement after 4 weeks.
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05904860
Sponsor's protocol ID
IRB 0350-22
Status last verified
Jun 2023
First submitted
6 Jun 2023
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Balasukumaran T, Olivier B, Ntsiea MV. The effectiveness of backward walking as a treatment for people with gait impairments: a systematic review and meta-analysis. Clin Rehabil. 2019 Feb;33(2):171-182. doi: 10.1177/0269215518801430. Epub 2018 Sep 19.

    PubMed 30229667
  • Bytyci I, Henein MY. Stride Length Predicts Adverse Clinical Events in Older Adults: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Jun 17;10(12):2670. doi: 10.3390/jcm10122670.

    PubMed 34204430
  • Cha YJ, Kim JD, Choi YR, Kim NH, Son SM. Effects of gait training with auditory feedback on walking and balancing ability in adults after hemiplegic stroke: a preliminary, randomized, controlled study. Int J Rehabil Res. 2018 Sep;41(3):239-243. doi: 10.1097/MRR.0000000000000295.

    PubMed 29782407
  • Feldman AG, Levin MF, Garofolini A, Piscitelli D, Zhang L. Central pattern generator and human locomotion in the context of referent control of motor actions. Clin Neurophysiol. 2021 Nov;132(11):2870-2889. doi: 10.1016/j.clinph.2021.08.016. Epub 2021 Sep 27.

    PubMed 34628342
  • Kondo K, Noonan KM, Freeman M, Ayers C, Morasco BJ, Kansagara D. Efficacy of Biofeedback for Medical Conditions: an Evidence Map. J Gen Intern Med. 2019 Dec;34(12):2883-2893. doi: 10.1007/s11606-019-05215-z. Epub 2019 Aug 14.

    PubMed 31414354
  • Maier M, Ballester BR, Verschure PFMJ. Principles of Neurorehabilitation After Stroke Based on Motor Learning and Brain Plasticity Mechanisms. Front Syst Neurosci. 2019 Dec 17;13:74. doi: 10.3389/fnsys.2019.00074. eCollection 2019.

    PubMed 31920570
  • McLellan AG, Slaght J, Craig CM, Mayo A, Senechal M, Bouchard DR. Can older adults improve the identification of moderate intensity using walking cadence? Aging Clin Exp Res. 2018 Jan;30(1):89-92. doi: 10.1007/s40520-017-0746-3. Epub 2017 Apr 4.

    PubMed 28378230
  • Park C, Oh-Park M, Dohle C, Bialek A, Friel K, Edwards D, Krebs HI, You JSH. Effects of innovative hip-knee-ankle interlimb coordinated robot training on ambulation, cardiopulmonary function, depression, and fall confidence in acute hemiplegia. NeuroRehabilitation. 2020;46(4):577-587. doi: 10.3233/NRE-203086.

    PubMed 32538882
  • Ronsse R, Puttemans V, Coxon JP, Goble DJ, Wagemans J, Wenderoth N, Swinnen SP. Motor learning with augmented feedback: modality-dependent behavioral and neural consequences. Cereb Cortex. 2011 Jun;21(6):1283-94. doi: 10.1093/cercor/bhq209. Epub 2010 Oct 28.

    PubMed 21030486
  • Rose DK, DeMark L, Fox EJ, Clark DJ, Wludyka P. A Backward Walking Training Program to Improve Balance and Mobility in Acute Stroke: A Pilot Randomized Controlled Trial. J Neurol Phys Ther. 2018 Jan;42(1):12-21. doi: 10.1097/NPT.0000000000000210.

    PubMed 29232308
  • Spencer J, Wolf SL, Kesar TM. Biofeedback for Post-stroke Gait Retraining: A Review of Current Evidence and Future Research Directions in the Context of Emerging Technologies. Front Neurol. 2021 Mar 30;12:637199. doi: 10.3389/fneur.2021.637199. eCollection 2021.

    PubMed 33859607
  • Steuer I, Guertin PA. Central pattern generators in the brainstem and spinal cord: an overview of basic principles, similarities and differences. Rev Neurosci. 2019 Jan 28;30(2):107-164. doi: 10.1515/revneuro-2017-0102.

    PubMed 30543520

Questions about this trial

What is this clinical trial studying?

A study testing Backward Gait Training and Forward Gait Training in people with Stroke, Ischemic, run by Shifa Tameer-e-Millat University at 1 site in Pakistan.

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 1 inclusion and 1 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 15 Jun 2023. 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 Pakistan. 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. 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 Manan Haider, PhD (+923334839810, m_manan.drs@stmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (time frame: 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 NCT05904860, which also lists 12 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 15 Jun 2023.

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