Stroke, IschemicNCT05221112
Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients
A study testing diagonal pattern training and single plane training in people with Stroke, Ischemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of PNF patterns Training on trunk balance and gait in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- diagonal pattern training and single plane training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2021to 15 Feb 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients whose onset of stroke was at least 6 months to two years
- Ability to maintain an independent standing posture for 30s, ability to walk 30m alone indoor.
- Patient with the ability to communicate enough and to understand oral instructions given by the therapist.
- Patients who were not using assistive devices
- Patients receiving drug therapy of internal medicine for the alleviation of spasticity.
Who cannot join
- Unconscious patients.
- Patients undergone Spine surgery.
- Patients with Hemi neglect.
- Sensory ataxia or cerebellar ataxia.
- Coronary heart disease (CHD) or peripheral arterial disease (PAD).
- Cardio respiratory problems.
Trial locations and contacts
1 site in 1 country.
About this study
To determine the effects of PNF patterns Training on trunk balance and gait in chronic stroke patients.
Read the detailed description
This study will be conducted to investigate the effects of PNF patterns training on the trunk control, balance, and gait ability of chronic stroke patients. Data will be collected from stroke patients from Government Mian Munshi hospital (DHQ) and Riphah Rehabilitation center. A consecutive sampling technique will be use which is based on 6 months' time period. TIS (Trunk Impairment Scale), BBS (Berg Balance Scale), 10 MWT (Meter Walk Test) will be used as a tool to collect the data. SPSS 21 version will be used for data entry and analysis.
This study will provide the effects of PNF patterns training on the trunk control, balance, and gait ability in chronic stroke patients. All possible patients will be taken using random sampling. Single plane training and diagonal pattern training will use. The subjects will randomly assign to the experiment group (diagonal pattern training) and the control group (single plane training). Diagonal pattern training will modified with proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.
Informed consent will be taken from all patients.
- Conditions
- Stroke, Ischemic
- Being tested
- diagonal pattern training, single plane training
- Keywords
- stroke, Gait Disorder, Balance; Disorder,
- Medical subject headings
- Ischemic Stroke, Stroke, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagonal pattern trainingOther
patients will receive proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.
single plane trainingOther
patients will receive single plane training of proprioceptive neuromuscular facilitation in control group
| Study group | Role | What they receive |
|---|---|---|
| diagonal pattern training | Experimental | diagonal pattern training group will involve performance of proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements. Receives: Other: diagonal pattern training |
| control group | Active comparator | in control group patients will perform movements in single plane Receives: Other: single plane training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Impairment Scale
This test is used to assess balance and function of trunk in stroke patients
Measured: Six months
Berg Balance Scale
To assess whole body balance
Measured: Six months
10 Meter Walk Test
To assess dynamic mobility
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 Sep 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies 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
- Model description
- total 30 subjects will be randomly assigned to the experiment group (diagonal pattern training) and the control group (single plane training).Diagonal pattern training will be modified with proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221112
- Sponsor's protocol ID
- REC/RCR & AHS/21/0218
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Criekinge T, Truijen S, Schroder J, Maebe Z, Blanckaert K, van der Waal C, Vink M, Saeys W. The effectiveness of trunk training on trunk control, sitting and standing balance and mobility post-stroke: a systematic review and meta-analysis. Clin Rehabil. 2019 Jun;33(6):992-1002. doi: 10.1177/0269215519830159. Epub 2019 Feb 22.
PubMed 30791703Zhu Z, Cui L, Yin M, Yu Y, Zhou X, Wang H, Yan H. Hydrotherapy vs. conventional land-based exercise for improving walking and balance after stroke: a randomized controlled trial. Clin Rehabil. 2016 Jun;30(6):587-93. doi: 10.1177/0269215515593392. Epub 2015 Jun 30.
PubMed 26130657Van Criekinge T, Saeys W, Hallemans A, Velghe S, Viskens PJ, Vereeck L, De Hertogh W, Truijen S. Trunk biomechanics during hemiplegic gait after stroke: A systematic review. Gait Posture. 2017 May;54:133-143. doi: 10.1016/j.gaitpost.2017.03.004. Epub 2017 Mar 4.
PubMed 28288334Dubey L, Karthikbabu S. Trunk proprioceptive neuromuscular facilitation influences pulmonary function and respiratory muscle strength in a patient with pontine bleed. Neurol India. 2017 Jan-Feb;65(1):183-184. doi: 10.4103/0028-3886.198193. No abstract available.
PubMed 28084270
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of PNF Patterns Training on Trunk Balance, and Gait in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05221112
- Acronym / sponsor ID
- REC/RCR & AHS/21/0218
- Conditions
- Stroke, Ischemic
- Keywords
- stroke, Gait Disorder, Balance; Disorder,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 2 Feb 2022 (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.
To determine the effects of PNF patterns Training on trunk balance and gait in chronic stroke patients.
Detailed description
This study will be conducted to investigate the effects of PNF patterns training on the trunk control, balance, and gait ability of chronic stroke patients. Data will be collected from stroke patients from Government Mian Munshi hospital (DHQ) and Riphah Rehabilitation center. A consecutive sampling technique will be use which is based on 6 months' time period. TIS (Trunk Impairment Scale), BBS (Berg Balance Scale), 10 MWT (Meter Walk Test) will be used as a tool to collect the data. SPSS 21 version will be used for data entry and analysis.
This study will provide the effects of PNF patterns training on the trunk control, balance, and gait ability in chronic stroke patients. All possible patients will be taken using random sampling. Single plane training and diagonal pattern training will use. The subjects will randomly assign to the experiment group (diagonal pattern training) and the control group (single plane training). Diagonal pattern training will modified with proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.
Informed consent will be taken from all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- total 30 subjects will be randomly assigned to the experiment group (diagonal pattern training) and the control group (single plane training).Diagonal pattern training will be modified with proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements.
| Arm | Type | Receives |
|---|---|---|
| diagonal pattern training | Experimental | Other: diagonal pattern trainingdiagonal pattern training group will involve performance of proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements. |
| control group | Active comparator | Other: single plane trainingin control group patients will perform movements in single plane |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic stroke patients whose onset of stroke was at least 6 months to two years
- Ability to maintain an independent standing posture for 30s, ability to walk 30m alone indoor.
- Patient with the ability to communicate enough and to understand oral instructions given by the therapist.
- Patients who were not using assistive devices
- Patients receiving drug therapy of internal medicine for the alleviation of spasticity.
Key exclusion criteria (6 listed)
- Unconscious patients.
- Patients undergone Spine surgery.
- Patients with Hemi neglect.
- Sensory ataxia or cerebellar ataxia.
- Coronary heart disease (CHD) or peripheral arterial disease (PAD).
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 |
|---|---|---|
| diagonal pattern trainingpatients will receive proprioceptive neuromuscular facilitation technique's chopping and lifting pattern to create 10 movements. | Other | diagonal pattern training |
| single plane trainingpatients will receive single plane training of proprioceptive neuromuscular facilitation in control group | Other | control group |
Primary outcome
Trunk Impairment Scale
Time frame: Six months
This test is used to assess balance and function of trunk in stroke patients
Berg Balance Scale
Time frame: Six months
To assess whole body balance
10 Meter Walk Test
Time frame: Six months
To assess dynamic mobility
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Background: PubMed 30791703Van Criekinge T, Truijen S, Schroder J, Maebe Z, Blanckaert K, van der Waal C, Vink M, Saeys W. The effectiveness of trunk training on trunk control, sitting and standing balance and mobility post-stroke: a systematic review and meta-analysis. Clin Rehabil. 2019 Jun;33(6):992-1002. doi: 10.1177/0269215519830159. Epub 2019 Feb 22.
- Background: PubMed 26130657Zhu Z, Cui L, Yin M, Yu Y, Zhou X, Wang H, Yan H. Hydrotherapy vs. conventional land-based exercise for improving walking and balance after stroke: a randomized controlled trial. Clin Rehabil. 2016 Jun;30(6):587-93. doi: 10.1177/0269215515593392. Epub 2015 Jun 30.
- Background: PubMed 28288334Van Criekinge T, Saeys W, Hallemans A, Velghe S, Viskens PJ, Vereeck L, De Hertogh W, Truijen S. Trunk biomechanics during hemiplegic gait after stroke: A systematic review. Gait Posture. 2017 May;54:133-143. doi: 10.1016/j.gaitpost.2017.03.004. Epub 2017 Mar 4.
- Background: PubMed 28084270Dubey L, Karthikbabu S. Trunk proprioceptive neuromuscular facilitation influences pulmonary function and respiratory muscle strength in a patient with pontine bleed. Neurol India. 2017 Jan-Feb;65(1):183-184. doi: 10.4103/0028-3886.198193. No abstract available.
- 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.
zeest hashmi, MSNMPT principal investigator
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 diagonal pattern training and single plane training in people with Stroke, Ischemic, 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 5 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 25 Apr 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?
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?
Trunk Impairment Scale (time frame: Six months). 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 NCT05221112, which also lists 4 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 25 Apr 2022.