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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05026099
Other study ID # Riphah/REC/01031 Mubbra
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2021
Est. completion date August 20, 2022

Study information

Verified date February 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 20, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Cognitive impairment - Abnormal synergic pattern - Rheumatoid arthritis or other hand impairments - Visual Impairment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Boxing training
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 Training
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

Locations

Country Name City State
Pakistan Iradah Rehabilitation Center Kalar Kahar Chakwal Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Erratum In: Stroke. 2019 Aug;50(8):e239. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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) week 8
Primary 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
week 8
Primary 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. week 8
Secondary 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:
Domain scores are composed of unweighted averages
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:
Mobility
Energy
Upper Extremity Function
Work and Productivity
Mood
Self-care
Social Roles
Family Roles
Vision
Language
Thinking
Personality
week 8
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