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StrokeNCT04820660

Task-oriented Progressive Resistance Strength Training and Balance Exercises on Lower Limb in Individuals With Stroke

A study testing Task orientated strengthening training and Balance training exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke is ranked as the number fifth cause of death and a main cause of disability in the United States. It affects the arteries which supply blood to and within the brain. If the blood supply to the brain is disrupted, it will not be able to receive oxygen and the nutrients which are transported by those arteries. Read more about this study

Who is it for?
Ages 45 to 60 years
Conditions the study is for
Stroke
What is being tested?
Task orientated strengthening training and Balance training exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 sitePakistan
Study dates
1 Mar 2019to 30 Dec 2019
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 45 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Hemiparetic from a single stroke occurring at least a year earlier, not presently receiving any rehabilitation services,
  • Participants should not be receiving any rehabilitation services
  • Participants should be able to walk 10 m independently without an assistive device
  • Participants should be medically stable enough to allow participation, and able to understand instructions and follow commands.

Who cannot join

  • Participants with any medical condition that would prevent participation in the training program
  • Participants with any uncontrolled health condition for which exercise is contraindicated.
  • Participants with any tumor or neurological signs.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Riphah IU

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effects of Task-oriented Progressive Resistance Strength Training and Balance Exercises in Functional Performance on Lower Limb in Individuals With Stroke

Stroke is ranked as the number fifth cause of death and a main cause of disability in the United States. It affects the arteries which supply blood to and within the brain. If the blood supply to the brain is disrupted, it will not be able to receive oxygen and the nutrients which are transported by those arteries. This leads to the death of brain cells having a magnificent effect on the function of that part.

Read the detailed description

This study was quasi-experimental trial, to compare the effectiveness of Progressive Resistive Strength Exercises and Balance Exercises in subjects with Stroke. Subjects with Stroke meeting the predetermined inclusion \& exclusion criteria were divided into two groups using lottery method. Pre assessment was done using Berg Balance Scale, Fugl Meyer Assessment - Lower Extremity and Step Test.

Subjects in one group were treated with Progressive Resistive Strength Training and other group was treated with Balance training. Each subject received 12 treatment sessions, with 03 treatment sessions per week. Results were recorded at the end of 3rd, 6th, 9th and 12th treatment sessions. Recorded values were analysed using SPSS.

Conditions
Stroke
Being tested
Task orientated strengthening training, Balance training exercises
Keywords
Balance, progressive resistance strength training
Medical subject headings
Stroke

What participants receive

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

  • Task orientated strengthening trainingOther

    1. Standing and reaching in different directions for objects located beyond arm's length to promote loading of the lower limbs and activation of lower limb muscles;
    2. Sit-to-stand from various chair heights to strengthen the lower limb extensor muscles;
    3. Stepping forward and backward onto blocks of various heights to strengthen the lower limb muscles;
    4. Stepping sideways onto blocks of various heights to strengthen the lower limb muscles;
    5. forward step-up onto blocks of various heights to strengthen the lower limb muscles;
    6. heel(s) raise and lower while maintaining in a standing posture to strengthen the plantar- flexor muscles.

    Each workstation was 5 min in duration for each exercise class. Each subject participated in a one-to-one therapy.

  • Balance training exercisesOther

    1. Stepping forward, backward, and sideways on the exercise step;
    2. Stepping over blocks of various heights;
    3. Standing up from a chair, walking four steps forward, performing a bilateral stool touch and walking backwards to the chair;
    4. Standing up from a chair, walking four steps forward, turning to the right, stepping over the exercise step, turning to the right again and walking forwards to the chair (repeat the exercise circuit in opposite direction);
    5. From a sitting position on a 65-cm Swiss ball, performing a range of motion and balance exercises (forward and backward rolling of the
    6. Arms; bending the trunk forward and side to side);
    7. Performing double-legged stance for 10 s;
    8. Performing tandem stance for 10 s;
    9. Rising from a chair without the use of the arms;
    10. Walking forward and backward with a tandem walking pattern (toes of one foot touching the heel of the foot in front);
    11. Performing single- legged stance for 10 s.
Study groups in NCT04820660
Study groupRoleWhat they receive
Task oriented Strength training groupExperimentalStanding and reaching in different directions Sit-to-stand Stepping forward and backward Stepping sideways onto blocks
Receives: Other: Task orientated strengthening training
Balance TrainingExperimentalStepping forward, backward, and sideways on the exercise step; Stepping over blocks of various heights; Standing up from a chair, From a sitting position on a 65-cm Swiss ball, Arms; bending the trunk forward and side to side); Performing double-legged stance Performing tandem stance Rising from a chair without the use of the arms; Walking forward and backward with a tandem walking pattern Performing single- legged stance
Receives: Other: Balance training exercises

What is being measured

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

  1. Berg Balance Scale (BBS)

    Zero indicates the lowest level of function and 4 the highest level of function. The total score ranges from 0 to 56.

    Measured: 4months

  2. Fugl Meyer Assessment Lower Extremity

    Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

    Measured: 4 months

Timeline

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

  1. First posted29 Mar 2021
  2. Study start1 Mar 2019
  3. Primary completion30 Oct 2019
  4. Study completion30 Dec 2019

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
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04820660
Sponsor's protocol ID
REC/Lhr/19/2033 Hira Javed
Status last verified
Mar 2021
First submitted
26 Mar 2021
Last updated
30 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PubMed 21571152

  • National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995 Dec 14;333(24):1581-7. doi: 10.1056/NEJM199512143332401.

    PubMed 7477192

  • van der Worp HB, van Gijn J. Clinical practice. Acute ischemic stroke. N Engl J Med. 2007 Aug 9;357(6):572-9. doi: 10.1056/NEJMcp072057. No abstract available.

    PubMed 17687132

  • Andersen KK, Olsen TS, Dehlendorff C, Kammersgaard LP. Hemorrhagic and ischemic strokes compared: stroke severity, mortality, and risk factors. Stroke. 2009 Jun;40(6):2068-72. doi: 10.1161/STROKEAHA.108.540112. Epub 2009 Apr 9.

    PubMed 19359645

  • Albers GW, Caplan LR, Easton JD, Fayad PB, Mohr JP, Saver JL, Sherman DG; TIA Working Group. Transient ischemic attack--proposal for a new definition. N Engl J Med. 2002 Nov 21;347(21):1713-6. doi: 10.1056/NEJMsb020987. No abstract available.

    PubMed 12444191

  • Lovett JK, Dennis MS, Sandercock PA, Bamford J, Warlow CP, Rothwell PM. Very early risk of stroke after a first transient ischemic attack. Stroke. 2003 Aug;34(8):e138-40. doi: 10.1161/01.STR.0000080935.01264.91. Epub 2003 Jul 10.

    PubMed 12855835

Questions about this trial

What is this clinical trial studying?

A study testing Task orientated strengthening training and Balance training exercises in people with Stroke, run by Riphah International 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Mar 2021. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (BBS) (time frame: 4months). The study lists 2 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 NCT04820660, which also lists 6 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 30 Mar 2021.

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Clinical Trial NCT04820660 | AzTrials