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AzTrials

StrokeNCT04823546

Comparison of Effects of Activity Base Therapy vs Strength Training on Gait Performance in Chronic Stroke

A study testing activity based therapy and Strength Training 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 a leading cause of disability worldwide affecting both male and female especially in older people. Functional independence and locomotion are hampered in stroke, therefore, affecting their quality of life. Read more about this study

Who is it for?
Ages 55 to 65 years
Conditions the study is for
Stroke
What is being tested?
activity based therapy and Strength Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 sitePakistan
Study dates
15 Feb 2020to 30 Dec 2020
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 55 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants were at least 6 months post stroke.
  • Ability to walk independent or with help of walking aids
  • Ischemic stroke patients included in study.
  • Mini mental state examination patients fully understand the commands

Who cannot join

  • Presence of orthopaedic problems.
  • Neurological disorders.
  • Psychological problems.
  • Cognitive issues.
  • People with severe visual issues.
  • Participants with other medical complications foot ulcers, orthopaedic or other neurological impedance

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Binash afzal

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Stroke is a leading cause of disability worldwide affecting both male and female especially in older people. Functional independence and locomotion are hampered in stroke, therefore, affecting their quality of life. Objective: To find the comparative effects of activity base therapy vs strength training on gait performance in chronic stroke patients.

Read the detailed description

It was a randomized controlled trial, conducted in physical therapy department of Sir Ganga Ram Hospital. 20 chronic stroke patients were equally divided into two groups. In group-A patients were treated with activity base therapy and in group-B patients were treated with strength training. Patients were treated for a total of 6 weeks (12 sessions), 1 hour in a day, 3 times per week. Patients were assessed using Timed Up and Go (TUG) test and Fugl Meyer Examination-Lower Extremity (FME-LE). SPSS 25 was used toanalyze the dat

Conditions
Stroke
Being tested
activity based therapy, Strength Training
Keywords
Activity based therapy, Chronic stroke, Gait, strength training, exercises
Medical subject headings
Stroke, Motor Activity

What participants receive

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

  • activity based therapyOther

    Standing and reaching (2) Sit-to-stand (3) Stepping forward and backward onto blocks (4) Stepping sideways onto blocks (5) Forward step up onto blocks (6) Raising and lowering of heel (7) Standing with the base of support constrained with feet in parallel and tandem conditions Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill; (11) Walking over various surfaces and obstacles;

  • Strength TrainingOther

    Strength training included for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances

Study groups in NCT04823546
Study groupRoleWhat they receive
Activity based therapyExperimentalActivity based training was done in 2 phases. exercise involve 1. Standing and reaching 2. Sit-to-stand 3. Stepping forward and backward Phase 2 Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill;
Receives: Other: activity based therapy
strength trainingActive comparatorStrength training for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances
Receives: Other: Strength Training

What is being measured

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

  1. Time Up and Go Test (TUG)

    Simple screening test that is a sensitive and specific measure of probability for falls among older adultsThe Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance.

    It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees.

    Measured: 2 months

  2. Fugl meyer for lower limb

    The fugal-meyer assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning in patient with post stroke hemiplegia.

    Measured: 2 months

Timeline

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

  1. First posted1 Apr 2021
  2. Study start15 Feb 2020
  3. Primary completion20 Oct 2020
  4. Study completion30 Dec 2020

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
Single blind
Who is masked
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04823546
Sponsor's protocol ID
REC/Lhr/20/2048 Anas Arshad
Status last verified
Mar 2021
First submitted
26 Mar 2021
Last updated
1 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Saleh MSM, Rehab NI, Aly SMA. Effect of aquatic versus land motor dual task training on balance and gait of patients with chronic stroke: A randomized controlled trial. NeuroRehabilitation. 2019;44(4):485-492. doi: 10.3233/NRE-182636.

    PubMed 31256082

  • Tisserand R, Armand S, Allali G, Schnider A, Baillieul S. Cognitive-motor dual-task interference modulates mediolateral dynamic stability during gait in post-stroke individuals. Hum Mov Sci. 2018 Apr;58:175-184. doi: 10.1016/j.humov.2018.01.012. Epub 2018 Mar 12.

    PubMed 29448162

  • Park HK, Lee HJ, Lee SJ, Lee WH. Land-based and aquatic trunk exercise program improve trunk control, balance and activities of daily living ability in stroke: a randomized clinical trial. Eur J Phys Rehabil Med. 2019 Dec;55(6):687-694. doi: 10.23736/S1973-9087.18.05369-8. Epub 2018 Oct 29.

    PubMed 30370752

  • Lund C, Dalgas U, Gronborg TK, Andersen H, Severinsen K, Riemenschneider M, Overgaard K. Balance and walking performance are improved after resistance and aerobic training in persons with chronic stroke. Disabil Rehabil. 2018 Oct;40(20):2408-2415. doi: 10.1080/09638288.2017.1336646. Epub 2017 Jun 9.

    PubMed 28597708

  • Lee HS, Park YJ, Park SW. The Effects of Virtual Reality Training on Function in Chronic Stroke Patients: A Systematic Review and Meta-Analysis. Biomed Res Int. 2019 Jun 18;2019:7595639. doi: 10.1155/2019/7595639. eCollection 2019.

    PubMed 31317037

  • Lamberti N, Straudi S, Malagoni AM, Argiro M, Felisatti M, Nardini E, Zambon C, Basaglia N, Manfredini F. Effects of low-intensity endurance and resistance training on mobility in chronic stroke survivors: a pilot randomized controlled study. Eur J Phys Rehabil Med. 2017 Apr;53(2):228-239. doi: 10.23736/S1973-9087.16.04322-7. Epub 2016 Sep 14.

    PubMed 27626795

  • Vahlberg B, Cederholm T, Lindmark B, Zetterberg L, Hellstrom K. Short-term and long-term effects of a progressive resistance and balance exercise program in individuals with chronic stroke: a randomized controlled trial. Disabil Rehabil. 2017 Aug;39(16):1615-1622. doi: 10.1080/09638288.2016.1206631. Epub 2016 Jul 14.

    PubMed 27415645

  • Wist S, Clivaz J, Sattelmayer M. Muscle strengthening for hemiparesis after stroke: A meta-analysis. Ann Phys Rehabil Med. 2016 Apr;59(2):114-24. doi: 10.1016/j.rehab.2016.02.001. Epub 2016 Mar 8.

    PubMed 26969343

  • Chan K, Phadke CP, Stremler D, Suter L, Pauley T, Ismail F, Boulias C. The effect of water-based exercises on balance in persons post-stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 May;24(4):228-235. doi: 10.1080/10749357.2016.1251742. Epub 2016 Nov 3.

    PubMed 27808012

  • Geiger M, Supiot A, Zory R, Aegerter P, Pradon D, Roche N. The effect of transcranial direct current stimulation (tDCS) on locomotion and balance in patients with chronic stroke: study protocol for a randomised controlled trial. Trials. 2017 Oct 23;18(1):492. doi: 10.1186/s13063-017-2219-6.

    PubMed 29061169

Questions about this trial

What is this clinical trial studying?

A study testing activity based therapy and Strength Training 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 6 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 1 Apr 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?

Time Up and Go Test (TUG) (time frame: 2 months). 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 NCT04823546, which also lists 10 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 1 Apr 2021.

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