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StrokeNCT05026099

Boxing Training for Upper Limb Functions, Balance, and Quality of Life in Stroke

A study testing Boxing training and Task Oriented 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

The World Health Organization's (WHO) definition of stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than a vascular origin'.Stroke has further three types… Read more about this study

Who is it for?
Ages 40 to 60 years
Conditions the study is for
Stroke
What is being tested?
Boxing training and Task Oriented Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePakistan
Study dates
15 Aug 2021to 20 Aug 2022
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 40 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Both genders
  • Age 40-60years
  • Middle Cerebral Artery Stroke
  • Fugyl Meyer score limit for upper limb:
  • Sub-acute and chronic (after 6 weeks)
  • Able to sit for 2mints independently

Who cannot join

  • Cognitive impairment
  • Abnormal synergic pattern
  • Rheumatoid arthritis or other hand impairments
  • Visual Impairment

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Iradah Rehabilitation Center Kalar Kahar

    Chakwal, Punjab Province

Other trials in Pakistan

About this study

Official title: Effects of Boxing Training on Upper Limb Function, Balance and Quality of Life in Stroke Patients

The World Health Organization's (WHO) definition of stroke is a clinical syndrome characterized by rapidly developing clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours or leading to death with no apparent cause other than a vascular origin'.Stroke has further three types i.e. ischemic, hemorrhagic, and transient ischemic stroke. As most gestures in daily life involve the upper limbs and hands, patients who cannot use their hands not only suffer from severe physical and psychological pain but also encounter difficulties in the activities of daily living that primarily involve upper limb function. Stroke patients have various problems such as asymmetrical posture, abnormal body balance, and decreased ability to move the weight.

Read the detailed description

As most gestures in daily life involve the upper limbs and hands, patients who cannot use their hands not only suffer from severe physical and psychological pain but also encounter difficulties in the activities of daily living that primarily involve upper limb function. Stroke patients have various problems such as asymmetrical posture, abnormal body balance, and decreased ability to move the weight. The loss of motion element involved in fine functions, and the above-mentioned problems can lead to decreased muscle cooperativity of the lower limbs while walking and may also result in an asymmetric gait due to imbalance in the ability to perform the exercise. Due to such persistent disorders, most stroke patients suffer from depression, problems in interpersonal relationships and social life, and a generally lower quality of life. Recent studies on the treatment of stroke patients reported that approaches such as more intensive and repetitive training as compared to conventional general and passive intervention, training related to reality, intervention involving motivation and active participation and forced induction exercise, visual exercise feedback, purpose-oriented training, and task-oriented training are more effective in promoting function after stroke onset. Virtual reality (VR) is frequently used in different disease groups at the clinic for rehabilitation purposes. Xbox Kinect, Nintendo Wii, Sony PlayStation, and Cyber Glove are among the most commonly used VR applications in rehabilitation. Several studies reported that VR applications improved both upper and lower extremity functions and promoted independence in performing activities of daily living. Task-specific training focused on both upper limbs and lower limbs could have a greater impact in improving mobility and physical activity in individuals with stroke but these studies have very little impact on balance, gait, and quality of life in patients with stroke. Previous studies reported that task-oriented training programs in stroke patients only focus on lower limb and upper limb function. The main barrier or limitation in task-oriented training is the repetition of tasks in an appropriate manner, and most patients lose interest and feel bored and there is less active participation during the performance of similar tasks. This will affect their performance and function and not very much effective intervention for treating stroke patients.

In recent years, it has been observed that boxing therapy has positive outcomes in individuals with neurological diseases. In the literature, the first study, including boxing therapy, was conducted in patients with Parkinson's disease, which concluded that boxing therapy was feasible and reliable for Parkinson's patients. As a form of high-intensity exercise, it is argued that goal-based activities such as boxing can be engaging and accessible for people with chronic diseases. Boxing incorporates high-intensity exercise, with movements of all regions of the body in a weight-bearing and aerobic context. Either non-contact or as a contact sport, boxing movements can be performed in sitting, standing, or as part of dynamic, complex movement sequences. In able-bodied people, high-intensity boxing programs performed for 50-minutes four times per week improved fitness, health, and well-being. The other preliminary on the effects of the sitting boxing program in stroke patients investigated and demonstrated that the sitting boxing program had a positive impact on upper extremity function, balance, gait, and quality of life in stroke patients.

Conditions
Stroke
Being tested
Boxing training, Task Oriented Training
Medical subject headings
Stroke

What participants receive

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

  • Boxing trainingOther

    Boxing training: warm-up. Mitt hitting, sandbag hitting, in sitting, cool down, Assessment after 4 weeks boxing training: warm-up. Mitt hitting, sandbag hitting, below hips, cool down, Assessment after 6 weeks Boxing training: warm-up. Mitt hitting, sandbag hitting, both inn sitting and standing, cool down, Post assessment

  • Task Oriented TrainingOther

    Task-oriented training: 6 tasks in sitting and standing position for both upper and lower limb Assessment after 4 weeks Task oriented training: 6 tasks in sitting and standing position for both upper and lower limb Assessment after 6 weeks Task oriented training: 6 tasks in sitting and standing position for both upper and lower limb Post assessment

Study groups in NCT05026099
Study groupRoleWhat they receive
Boxing training programExperimentalThe program will start with a warm-up session involving breathing and stretching of the trunk and limbs for 5 minutes. The program will include mitt hitting and sand bag hitting for 10 minutes, with a 2-minute rest period. Thereafter, stretching of the trunk and limbs will be performed for 5minutes, similar to the warm-up
Receives: Other: Boxing training
Task Oriented Training ProgramActive comparatorUpper limb Exercises: Sitting position: open covered pots of different sizes and transfer the flour to a cup with a spoon, then close the pot.Sitting position: pick up coins and cards on the table and put the coins in a pot and gather the cards.Sitting position: write and/or draw pictures on a piece of paper.Sitting position: open a safe box with a key, pick up small objects inside the box, and transfer them to a pot, then lock the safe box Sitting position: pick up and transfer jars, bottles, and glasses of different sizes and weights located on a table. Transfer the liquid contents from jars and bottles to glasses Sitting position: throw and catch balls (in pairs)
Receives: Other: Task Oriented Training

What is being measured

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

  1. Fugl-Meyer Assessment

    A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed). Specific descriptions for performance accompany individual test items. Subtests exist for Upper extremity function, Lower extremity function, balance, sensation, Range of Motion, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., Upper extremity maximum score is 66, Lower extremity score 34; balance score 14)

    Measured: week 8

  2. Wolf Motor Function Test

    the Wolf Motor Function Test consists of 17 items Composed of 3 parts:

    • Time
    • Functional ability
    • Strength Includes 15 function-based tasks and 2 strength-based tasks Performance time is referred to as Wolf Motor Function Test-Time. Functional ability is referred to as Wolf Motor Function Test. Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks Examiners should test the less affected upper extremity followed by the most affected side. Uses a 6-point ordinal scale "0" = "does not attempt with the involved arm" to "5" = "arm does participate; movement appears to be normal." The maximum score is 75 Lower scores are indicative of lower functioning levels Wolf Motor Function Test Time allows 120 seconds per task

    Measured: week 8

  3. Berg Balance Scale

    The maximum score that can be reached is 56 and each item possesses an ordinal scale of five alternatives ranging from 0 to 4 points.

    Measured: week 8

Secondary outcomes (1)
  1. Stroke Specific Quality of life

    used to assess quality of life in stroke patients. 49 items Items are assessed on 5-point Guttman-type scales. Each item is answered using 1 of 3 different response sets.

    Provides both summary and domain specific scores:

    1. Domain scores are composed of unweighted averages
    2. Summary scores are composed of an unweighted average of the 12 domain average scores Scores range from 49-245. Higher scores indicate better functioning.

    The 12 domains include:

    1. Mobility
    2. Energy
    3. Upper Extremity Function
    4. Work and Productivity
    5. Mood
    6. Self-care
    7. Social Roles
    8. Family Roles
    9. Vision
    10. Language
    11. Thinking
    12. Personality

    Measured: week 8

Timeline

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

  1. First posted30 Aug 2021
  2. Study start15 Aug 2021
  3. Primary completion20 Aug 2022
  4. Study completion20 Aug 2022

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
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05026099
Sponsor's protocol ID
Riphah/REC/01031 Mubbra
Status last verified
Feb 2023
First submitted
23 Aug 2021
Last updated
24 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

    PubMed 23652265
  • Ersoy C, Iyigun G. Boxing training in patients with stroke causes improvement of upper extremity, balance, and cognitive functions but should it be applied as virtual or real? Top Stroke Rehabil. 2021 Mar;28(2):112-126. doi: 10.1080/10749357.2020.1783918. Epub 2020 Jun 23.

    PubMed 32574096
  • Duncan PW, Horner RD, Reker DM, Samsa GP, Hoenig H, Hamilton B, LaClair BJ, Dudley TK. Adherence to postacute rehabilitation guidelines is associated with functional recovery in stroke. Stroke. 2002 Jan;33(1):167-77. doi: 10.1161/hs0102.101014.

    PubMed 11779907
  • Park J, Gong J, Yim J. Effects of a sitting boxing program on upper limb function, balance, gait, and quality of life in stroke patients. NeuroRehabilitation. 2017;40(1):77-86. doi: 10.3233/NRE-161392.

    PubMed 27792020
  • 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
  • Kwakkel G, van Wegen EEH, Burridge JH, Winstein CJ, van Dokkum LEH, Alt Murphy M, Levin MF, Krakauer JW; ADVISORY group. Standardized Measurement of Quality of Upper Limb Movement After Stroke: Consensus-Based Core Recommendations From the Second Stroke Recovery and Rehabilitation Roundtable. Neurorehabil Neural Repair. 2019 Nov;33(11):951-958. doi: 10.1177/1545968319886477. Epub 2019 Oct 29.

    PubMed 31660781
  • Feys HM, De Weerdt WJ, Selz BE, Cox Steck GA, Spichiger R, Vereeck LE, Putman KD, Van Hoydonck GA. Effect of a therapeutic intervention for the hemiplegic upper limb in the acute phase after stroke: a single-blind, randomized, controlled multicenter trial. Stroke. 1998 Apr;29(4):785-92. doi: 10.1161/01.str.29.4.785.

    PubMed 9550512
  • Rodriguez GM, Aruin AS. The effect of shoe wedges and lifts on symmetry of stance and weight bearing in hemiparetic individuals. Arch Phys Med Rehabil. 2002 Apr;83(4):478-82. doi: 10.1053/apmr.2002.31197.

    PubMed 11932848

Questions about this trial

What is this clinical trial studying?

A study testing Boxing training and Task Oriented 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 6 inclusion and 4 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 24 Feb 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?

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?

Fugl-Meyer Assessment (time frame: week 8). The study lists 3 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 NCT05026099, which also lists 8 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 24 Feb 2023.

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