Chronic StrokeNCT05033873
Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients
A study testing Universal Exercise Unit Therapy (UEU) and Sling Exercise Therapt (SET) in people with Chronic Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Stroke occurred when blood supply to brain or a part of brain is disturbed due to clot (ischaemic stroke) or due rupture of small vessels (hemorrhagic stroke) in brain and causes bleeding in brain cells. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Universal Exercise Unit Therapy (UEU) and Sling Exercise Therapt (SET)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2021to 30 Dec 2023
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with chronic (course of disease at least six month)
- Recently discharge from in-patients setting with in 06 month of onset
- Hemiplegia (either right or left)
- Both gender
- Age between 30 to 70
- Medically stable
Show all 9Show fewer
- No balance disorders before this stroke.
- History of mental
- illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE > 25)
Who cannot join
- Stroke Patient with complication like shoulder hand syndrome, adhesive capsulitis or shoulder partial dislocation
- Stroke patients with behavioral issue, significant cognitive deficit
- Patients with arthritis and fracture
- Chronic stroke with deformities
- Serious viscera dysfunction, such as cardiovascular system,
- Lung, liver and kidney
Show all 11Show fewer
- History of mental
- Illness or severe cognitive impairment (MINI-MENTAL SCALE SCORE > 25)
- Audio-visual understanding
- obstacle, unable to cooperate with instructions;
- Infection and ulcer skin
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah Rehabilitation Center
Lahore, Punjab Province
Rabiya Noor, PhD, rabiya.noor@riphah.edu.pk
Farjad Afzal, PhD*
About this study
Official title: Comparison of Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients
Stroke occurred when blood supply to brain or a part of brain is disturbed due to clot (ischaemic stroke) or due rupture of small vessels (hemorrhagic stroke) in brain and causes bleeding in brain cells. The prevalence of stroke was 1.2 % (1200/100,000) in Pakistan, 3.1% in China and it is 44.29 to 559/100,000 in different parts of the world. Leading cause of stroke is hypertension. The aim of study will be to compare universal exercise unit therapy with sling exercise therapy on lower limb kinematics, disability, balance and quality of life in chronic stroke patients.
Read the detailed description
This will be randomized controlled trial. Study will be conducted at Khawaja Arshed Hospital Sargodha. Duration of intervention will be 08 weeks, 5 sessions in a week, total 40 sessions. Duration of single session will be one hour. A convenient sample of n patients fulfilling the inclusion and exclusion criteria will be selected from in-patient settings of various hospitals from the city Sargodha and will be allocated randomly into three groups equally after taking informed consent. Group A will obtain Universal Exercise Unit Therapy. Group B will obtain Sling Exercise Therapy and Group C will be control and will receive routine physical therapy. Outcome will be measured at baseline, 04 weeks and 08 weeks. Outcome measurement tools will be Berg balance scale, Barthel index, Short form 12 (SF-12), Trunk impairment scale, functional reach test and smart phone motion analysis for lower limb kinematics. Scores will be measure in mean and SD. Results of intervention will be comparing by using one way ANOVA by using IBM SPSS version 21.0
- Conditions
- Chronic Stroke
- Being tested
- Universal Exercise Unit Therapy (UEU), Sling Exercise Therapt (SET), Routine Physical Therapy / Control Group
- Keywords
- Motion analysis, Universal exercise unit, Sling exercise therapy, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal Exercise Unit Therapy (UEU)Other
Also called Group A
Standing, walk standing, half standing, kneel standing, half kneel standing, quadruped position, three point quadruped , alternative quadruped , transitions, walking all these will be done in Universal Exercise Unit with a standardized protocol regimen.
Sling Exercise Therapt (SET)Other
Also called Group B
- The patient's bilateral knee joints/feet will be suspended by a rope belt, and then the patient's pelvis will be elevated and maintained in supine or lateral position, adding flexion and extension training to lower limb if permitted.
- In supine or lateral position, with patient's head, trunk and pelvis fixed, the therapist will use appropriate elastic bands to assist patient's limbs to do passive-power assisted-power resistance training in all directions (bending, stretch, outreach, and adduction).
- The patient's chest and abdomen will be suspended by a wide elastic band, positioned him-self in the prone position with the fulcrum of bilateral elbows and knees, and then the torso swayed in all directions, therapists could assist
- Target elbow and wrist will be suspended, according to the patient's ability to do passive/active open and close chain movement
Routine Physical Therapy / Control GroupOther
Also called Group C
Control group will receive routine physiotherapy with duration one hour including
- Active and passive joint movement
- Muscle strength training
- Bridging exercises
- Balance training in sitting and standing positions, according to the patients' functional state.
- Weight bearing exercises on affected Limbs
| Study group | Role | What they receive |
|---|---|---|
| Group A: Universal Exercise Unit Therapy (UEU) | Experimental | This experimental group will be given universal exercise unit therapy. Receives: Other: Universal Exercise Unit Therapy (UEU) |
| Group B: Sling Exercise Therapy (SET) | Experimental | This experimental group will be given sling exercise therapy Receives: Other: Sling Exercise Therapt (SET) |
| Group C: Control Group | Other | Control group will be given routine physical therapy Receives: Other: Routine Physical Therapy / Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
THE BERG BALANCE SCALE: (BALANCE FUNCTION)
This scale will be used to check the balance of the patients during the functional activities. Scale consists of 14 tasks and each task can be scored between 0 and 4. Overall balance score ranges from 0 to 56. 0 score is showing severely damage balance and 56 score is showing excellent balance. A score below 40 indicate the risk of falling in particular function.
Measured: 2 months
BARTHEL INDEX: (FUNCTIONAL ABILITY)
This index is used to measure the activities of daily life, having total 10 items and can be scored from 0 to 100.
Measured: 2 months
SHORT FORM 12 (SF-12): (QUALITY OF LIFE)
This survey contains 12 items divided into eight domains: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role-emotional (RE), and mental health (MH). According to the calculation formula, raw scores were converted into final scores. As scores increased, health status and quality of life increased for the subject.
Measured: 2 months
SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING
Sagittal plane hip, knee, and ankle angle and rear foot eversion will be assessed by using the Coach's Eye Smart phone application
Measured: 2 months
FUNCTIONAL REACH TEST
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the lengths of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.
Measured: 2months
TRUNK IMPAIRMENT SCALE
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start15 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PhD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033873
- Sponsor's protocol ID
- REC/RCR&AHS/21/1108
- Status last verified
- Dec 2022
- First submitted
- 26 Jun 2021
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajkumar S, Chandra SB. Recent advances in treatment of cerebral ischemic stroke. Medicine. 2021;10(1):1.
Busl KM, Greer DM. Hypoxic-ischemic brain injury: pathophysiology, neuropathology and mechanisms. NeuroRehabilitation. 2010;26(1):5-13. doi: 10.3233/NRE-2010-0531.
PubMed 20130351Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.
PubMed 33235553Yi X, Luo H, Zhou J, Yu M, Chen X, Tan L, Wei W, Li J. Prevalence of stroke and stroke related risk factors: a population based cross sectional survey in southwestern China. BMC Neurol. 2020 Jan 7;20(1):5. doi: 10.1186/s12883-019-1592-z.
PubMed 31910820Kamalakannan S, Gudlavalleti ASV, Gudlavalleti VSM, Goenka S, Kuper H. Incidence & prevalence of stroke in India: A systematic review. Indian J Med Res. 2017 Aug;146(2):175-185. doi: 10.4103/ijmr.IJMR_516_15.
PubMed 29265018Venketasubramanian N, Yoon BW, Pandian J, Navarro JC. Stroke Epidemiology in South, East, and South-East Asia: A Review. J Stroke. 2017 Sep;19(3):286-294. doi: 10.5853/jos.2017.00234. Epub 2017 Sep 29.
PubMed 29037005Hussein ZA. Strength training versus chest physical therapy on pulmonary functions in children with Down syndrome. Egyptian Journal of Medical Human Genetics. 2017;18(1):35-9.
Wooten A. Universal Exercise Unit for Treatment of a Child Following Hemispherectomy: A Case Report. 2017.
Salim ASM. Effect of universal exercise unit on standing in spastic diaplegia. 2013.
Olama KA, Elnahhas AM, Rajab SH. Effect of universal exercise unit on balance in children with spastic Diplegia.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Universal Exercise Unit Therapy With Sling Exercise Therapy on Lower Limb Kinematics in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05033873
- Acronym / sponsor ID
- REC/RCR&AHS/21/1108
- Conditions
- Chronic Stroke
- Keywords
- Motion analysis, Universal exercise unit, Sling exercise therapy, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke occurred when blood supply to brain or a part of brain is disturbed due to clot (ischaemic stroke) or due rupture of small vessels (hemorrhagic stroke) in brain and causes bleeding in brain cells. The prevalence of stroke was 1.2 % (1200/100,000) in Pakistan, 3.1% in China and it is 44.29 to 559/100,000 in different parts of the world. Leading cause of stroke is hypertension. The aim of study will be to compare universal exercise unit therapy with sling exercise therapy on lower limb kinematics, disability, balance and quality of life in chronic stroke patients.
Detailed description
This will be randomized controlled trial. Study will be conducted at Khawaja Arshed Hospital Sargodha. Duration of intervention will be 08 weeks, 5 sessions in a week, total 40 sessions. Duration of single session will be one hour. A convenient sample of n patients fulfilling the inclusion and exclusion criteria will be selected from in-patient settings of various hospitals from the city Sargodha and will be allocated randomly into three groups equally after taking informed consent. Group A will obtain Universal Exercise Unit Therapy. Group B will obtain Sling Exercise Therapy and Group C will be control and will receive routine physical therapy. Outcome will be measured at baseline, 04 weeks and 08 weeks. Outcome measurement tools will be Berg balance scale, Barthel index, Short form 12 (SF-12), Trunk impairment scale, functional reach test and smart phone motion analysis for lower limb kinematics. Scores will be measure in mean and SD. Results of intervention will be comparing by using one way ANOVA by using IBM SPSS version 21.0
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Universal Exercise Unit Therapy (UEU) | Experimental | Other: Universal Exercise Unit Therapy (UEU)This experimental group will be given universal exercise unit therapy. |
| Group B: Sling Exercise Therapy (SET) | Experimental | Other: Sling Exercise Therapt (SET)This experimental group will be given sling exercise therapy |
| Group C: Control Group | Other | Other: Routine Physical Therapy / Control GroupControl group will be given routine physical therapy |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with chronic (course of disease at least six month)
- Recently discharge from in-patients setting with in 06 month of onset
- Hemiplegia (either right or left)
- Both gender
- Age between 30 to 70
Key exclusion criteria (11 listed)
- Stroke Patient with complication like shoulder hand syndrome, adhesive capsulitis or shoulder partial dislocation
- Stroke patients with behavioral issue, significant cognitive deficit
- Patients with arthritis and fracture
- Chronic stroke with deformities
- Serious viscera dysfunction, such as cardiovascular system,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Universal Exercise Unit Therapy (UEU)Also: Group AStanding, walk standing, half standing, kneel standing, half kneel standing, quadruped position, three point quadruped , alternative quadruped , transitions, walking all these will be done in Universal Exercise Unit with a standardized protocol regimen. | Other | Group A: Universal Exercise Unit Therapy (UEU) |
| Sling Exercise Therapt (SET)Also: Group B1. The patient's bilateral knee joints/feet will be suspended by a rope belt, and then the patient's pelvis will be elevated and maintained in supine or lateral position, adding flexion and extension training to lower limb if permitted. 2. In supine or lateral position, with patient's head, trunk and pelvis fixed, the therapist will use appropriate elastic bands to assist patient's limbs to do passive-power assisted-power resistance training in all directions (bending, stretch, outreach, and adduction). 3. The patient's chest and abdomen will be suspended by a wide elastic band, positioned him-self in the prone position with the fulcrum of bilateral elbows and knees, and then the torso swayed in all directions, therapists could assist 4. Target elbow and wrist will be suspended, according to the patient's ability to do passive/active open and close chain movement | Other | Group B: Sling Exercise Therapy (SET) |
| Routine Physical Therapy / Control GroupAlso: Group CControl group will receive routine physiotherapy with duration one hour including * Active and passive joint movement * Muscle strength training * Bridging exercises * Balance training in sitting and standing positions, according to the patients' functional state. * Weight bearing exercises on affected Limbs | Other | Group C: Control Group |
Primary outcome
THE BERG BALANCE SCALE: (BALANCE FUNCTION)
Time frame: 2 months
This scale will be used to check the balance of the patients during the functional activities. Scale consists of 14 tasks and each task can be scored between 0 and 4. Overall balance score ranges from 0 to 56. 0 score is showing severely damage balance and 56 score is showing excellent balance. A score below 40 indicate the risk of falling in particular function.
BARTHEL INDEX: (FUNCTIONAL ABILITY)
Time frame: 2 months
This index is used to measure the activities of daily life, having total 10 items and can be scored from 0 to 100.
SHORT FORM 12 (SF-12): (QUALITY OF LIFE)
Time frame: 2 months
This survey contains 12 items divided into eight domains: physical function (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social function (SF), role-emotional (RE), and mental health (MH). According to the calculation formula, raw scores were converted into final scores. As scores increased, health status and quality of life increased for the subject.
SMART PHONE MOTION ANALYSIS FOR LOWER LIMB KINEMATICS DURING WALKING
Time frame: 2 months
Sagittal plane hip, knee, and ankle angle and rear foot eversion will be assessed by using the Coach's Eye Smart phone application
FUNCTIONAL REACH TEST
Time frame: 2months
Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task. In standing, measures the distance between the lengths of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support.
TRUNK IMPAIRMENT SCALE
Time frame: 2 Months
The total score for TIS ranges between 0 for a minimal performance to 23 for a perfect performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- BackgroundRajkumar S, Chandra SB. Recent advances in treatment of cerebral ischemic stroke. Medicine. 2021;10(1):1.
- Background: PubMed 20130351Busl KM, Greer DM. Hypoxic-ischemic brain injury: pathophysiology, neuropathology and mechanisms. NeuroRehabilitation. 2010;26(1):5-13. doi: 10.3233/NRE-2010-0531.
- Background: PubMed 33235553Sherin A, Ul-Haq Z, Fazid S, Shah BH, Khattak MI, Nabi F. Prevalence of stroke in Pakistan: Findings from Khyber Pakhtunkhwa integrated population health survey (KP-IPHS) 2016-17. Pak J Med Sci. 2020 Nov-Dec;36(7):1435-1440. doi: 10.12669/pjms.36.7.2824.
- Background: PubMed 31910820Yi X, Luo H, Zhou J, Yu M, Chen X, Tan L, Wei W, Li J. Prevalence of stroke and stroke related risk factors: a population based cross sectional survey in southwestern China. BMC Neurol. 2020 Jan 7;20(1):5. doi: 10.1186/s12883-019-1592-z.
- Background: PubMed 29265018Kamalakannan S, Gudlavalleti ASV, Gudlavalleti VSM, Goenka S, Kuper H. Incidence & prevalence of stroke in India: A systematic review. Indian J Med Res. 2017 Aug;146(2):175-185. doi: 10.4103/ijmr.IJMR_516_15.
- Background: PubMed 29037005Venketasubramanian N, Yoon BW, Pandian J, Navarro JC. Stroke Epidemiology in South, East, and South-East Asia: A Review. J Stroke. 2017 Sep;19(3):286-294. doi: 10.5853/jos.2017.00234. Epub 2017 Sep 29.
- BackgroundHussein ZA. Strength training versus chest physical therapy on pulmonary functions in children with Down syndrome. Egyptian Journal of Medical Human Genetics. 2017;18(1):35-9.
- BackgroundWooten A. Universal Exercise Unit for Treatment of a Child Following Hemispherectomy: A Case Report. 2017.
- BackgroundSalim ASM. Effect of universal exercise unit on standing in spastic diaplegia. 2013.
- BackgroundOlama KA, Elnahhas AM, Rajab SH. Effect of universal exercise unit on balance in children with spastic Diplegia.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabiya Noor, PhD study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Universal Exercise Unit Therapy (UEU) and Sling Exercise Therapt (SET) in people with Chronic 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabiya Noor, PhD (03344355660, rabiya.noor@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
THE BERG BALANCE SCALE: (BALANCE FUNCTION) (time frame: 2 months). The study lists 6 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 NCT05033873, 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 8 Dec 2022.