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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Boxing training
Task Oriented Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iradah Rehabilitation Center Kalar Kahar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Boxing training program

Task Oriented Training Program

Arm Description

The 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

Upper 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)

Outcomes

Primary Outcome Measures

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)
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
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 23, 2021
Last Updated
February 23, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05026099
Brief Title
Boxing Training for Upper Limb Functions, Balance, and Quality of Life in Stroke
Official Title
Effects of Boxing Training on Upper Limb Function, Balance and Quality of Life in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boxing training program
Arm Type
Experimental
Arm Description
The 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
Arm Title
Task Oriented Training Program
Arm Type
Active Comparator
Arm Description
Upper 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)
Intervention Type
Other
Intervention Name(s)
Boxing training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Task Oriented Training
Intervention Description
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
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment
Description
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)
Time Frame
week 8
Title
Wolf Motor Function Test
Description
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
Time Frame
week 8
Title
Berg Balance Scale
Description
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.
Time Frame
week 8
Secondary Outcome Measure Information:
Title
Stroke Specific Quality of life
Description
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
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iradah Rehabilitation Center Kalar Kahar
City
Chakwal
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23652265
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.
Results Reference
background
PubMed Identifier
32574096
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.
Results Reference
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PubMed Identifier
11779907
Citation
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.
Results Reference
background
PubMed Identifier
27792020
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.
Results Reference
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PubMed Identifier
21571152
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.
Results Reference
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PubMed Identifier
31660781
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.
Results Reference
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PubMed Identifier
9550512
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.
Results Reference
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PubMed Identifier
11932848
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.
Results Reference
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Boxing Training for Upper Limb Functions, Balance, and Quality of Life in Stroke

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