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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05429944
Other study ID # REC//22/0203 Tabeer Sheikh
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 15, 2022
Est. completion date February 28, 2023

Study information

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

Clinical Trial Summary

Through this study we compare the the effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors. This study will be a randomized controlled trial will recruit a sample of 39 participants through non-probability consecutive sampling technique. After satisfying the inclusion criteria, participants will be divided into three groups. The first group will receive motor relearning program for 6 weeks, 3 times per week for 30 minutes, along with the conventional therapy. The second group will receive proprioceptive neuromuscular facilitation for 6 weeks, 3 times per week for 30 minutes, along with conventional therapy. The third group will only receive conventional the conventional therapy.


Description:

One study revealed that both PNF and CIMT were effective in the management of upper limb chronic post- stroke patients. However, CIMT is the preferred technique for upper limb function recovery. Another experimental study was conducted on comparison between proprioceptive neuromuscular facilitation versus mirror therapy enhances gait and balance in paretic lower limb in acute stroke. In this study patients are randomly divided into two groups. According to statistical analysis this study shows that both the techniques Group A (Proprioceptive Neuromuscular Facilitation) and Group B (Mirror Therapy) were individually effective in improving gait and balance. While comparing both the techniques there is a significant difference present in the group. So, Group A is more effective in enhancing gait and balance in paretic lower limb after acute Stroke. Another randomized control trial was conducted on comparing the effects of motor relearning programs and mirror therapy for improving upper limb motor function in stroke patient. This study concluded that MRP and MT were found to be effective in improving upper limb motor function of stroke patients, but the former was more effective than the later. Another comparative study was conducted on motor relearning program versus proprioceptive neuro-muscular facilitation technique for improving basic mobility in chronic stroke patients- According to the results he concluded that MRP is more effective then PNF for improving basic mobility of sit to stand and walking in chronic stroke subjects and subjects were able to maintain their basic mobility at one month follow up also. Previous studies have compared only a single intervention with controls; however, this study aims to compare two different interventions in addition to comparison with the control groups. All these interventions previously used focus on the functional activities as a training component after stroke and have shown some degree of improvement in the functional outcome of the upper limb, but still, there is a paucity of literature on which intervention improves motor performance in an optimum timeframe during the subacute phase of stroke. Given this gap in the literature, a study is needed to elucidate the comparative effects of motor relearning program and proprioceptive neuromuscular facilitation on upper limb motor performance and quality of life in sub-acute stroke survivors.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date February 28, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Age between 40-70 years are included. - Both genders are included - Hemiplegic ischemic stroke of both sides - Participants with sub-acute Stroke (from 1 week to 6 months). - Non- aphasic stroke patients. - Clinically stable patients. Exclusion Criteria: - Recurrent Stroke - Patients with other neurological conditions and deficits. - Patients with other orthopedic condition like frozen shoulder or unhealed fracture of upper limb.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Motor Relearning Program
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
Proprioceptive Neuromuscular Facilitation
The techniques administered included Rhythmic Initiation, Slow Reversal and Agonistic Reversal. The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.
Conventional Physical Therapy
The exercise will be performed for approximately 30 minutes, 3 times a week for 6 weeks.

Locations

Country Name City State
Pakistan PSRD, Ittefaq Hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (8)

Bai Z, Zhang J, Zhang Z, Shu T, Niu W. Comparison Between Movement-Based and Task-Based Mirror Therapies on Improving Upper Limb Functions in Patients With Stroke: A Pilot Randomized Controlled Trial. Front Neurol. 2019 Mar 26;10:288. doi: 10.3389/fneur.2019.00288. eCollection 2019. — View Citation

Batool S, Soomro N, Amjad F, Fauz R. To compare the effectiveness of constraint induced movement therapy versus motor relearning programme to improve motor function of hemiplegic upper extremity after stroke. Pak J Med Sci. 2015 Sep-Oct;31(5):1167-71. doi: 10.12669/pjms.315.7910. — View Citation

Diaz-Arribas MJ, Martin-Casas P, Cano-de-la-Cuerda R, Plaza-Manzano G. Effectiveness of the Bobath concept in the treatment of stroke: a systematic review. Disabil Rehabil. 2020 Jun;42(12):1636-1649. doi: 10.1080/09638288.2019.1590865. Epub 2019 Apr 24. — View Citation

Guiu-Tula FX, Cabanas-Valdes R, Sitja-Rabert M, Urrutia G, Gomara-Toldra N. The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol. BMJ Open. 2017 Dec 12;7(12):e016739. doi: 10.1136/bmjopen-2017-016739. — View Citation

Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245. — View Citation

Pickering RL, Hubbard IJ, Baker KG, Parsons MW. Assessment of the upper limb in acute stroke: the validity of hierarchal scoring for the Motor Assessment Scale. Aust Occup Ther J. 2010 Jun;57(3):174-82. doi: 10.1111/j.1440-1630.2009.00810.x. — View Citation

Singer B, Garcia-Vega J. The Fugl-Meyer Upper Extremity Scale. J Physiother. 2017 Jan;63(1):53. doi: 10.1016/j.jphys.2016.08.010. Epub 2016 Oct 17. No abstract available. — View Citation

Ullah I, Arsh A, Zahir A, Jan S. Motor relearning program along with electrical stimulation for improving upper limb function in stroke patients: A quasi experimental study. Pak J Med Sci. 2020 Nov-Dec;36(7):1613-1617. doi: 10.12669/pjms.36.7.2351. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer Assessment Upper Extremity (FMA-UE) Changes from baseline The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. The motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. Each item consists of a 3- point scale (0, 1, and 2), with a total maximum score of 66. 6 weeks
Secondary Modified Ashworth Scale (MAS) It is used to assess spasticity. its performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension the point at which the first soft resistance is met. Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion. 6 weeks
Secondary Motor Assessment Scale The MAS was originally designed to assess eight subsets of motor function and one subset of muscle tone. The upper limb subscale (UL-MAS) consists of subset 6: 'Upper Arm Activity', subset 7: 'Hand Movements', and subset 'Advanced Hand Activities'. 6 weeks
Secondary Stroke Impact Scale It is a stroke-specific, self-report, health status measure. It was designed to assess multidimensional Stroke outcomes, including strength, hand function Activities of Daily Living/ Instrumental Activities of Daily Living (ADL/IADL), mobility, communication, emotion, memory and thinking, and participation. 6 weeks
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