NCT05075109

Brief Summary

study aims to evaluate the efficacy of high and low frequency TENS on spasticity, strength and functional status in stroke patients. It may provide further knowledge concerning the use of TENS for motor impairments in stroke patients and may clarify ambiguities to some extent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

September 17, 2021

Last Update Submit

January 13, 2023

Conditions

Stroke

Keywords

SpasticityUpper limbTENS

Outcome Measures

Primary Outcomes (1)

  • Modified Ashworth Scale (MAS)

    Modified Ashworth Scale (MAS) is a subjective method used clinically to measure spasticity. It has verified validity to test spasticity. MAS is six point scale (0,1,2,3,4,5) with a 0 indicating no resistance and 5 indicating rigidity. It has good intra and inter-rater reliability with inter-rater reliability of r= 0.92 and intra-rater reliability at r=0.86.

    8 weeks

Secondary Outcomes (2)

  • Manual Muscle Testing (MMT)

    8 weeks

  • Action Research Arm Test (ARAT)

    8 weeks

Study Arms (3)

High Frequency TENS

EXPERIMENTAL

high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.

Device: High Frequency TENS

Low Frequency TENS

EXPERIMENTAL

low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks with task related training.

Device: Low Frequency TENS

Task Related Training

ACTIVE COMPARATOR

postural control, shoulder mobilization, weight bearing exercises, functional activities that will comprise of simple tasks to more advanced movement patterns

Other: Task Related Training

Interventions

High Frequency TENSDEVICE

30 minutes of high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.

High Frequency TENS
Low Frequency TENSDEVICE

30 minutes of low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks. And combined with 30 minutes of TRT.

Low Frequency TENS
Task Related TrainingOTHER

Each session of TRT would include: 1\. postural control, 2. shoulder mobilization, 3. weight bearing exercises 4. Functional activities that will comprise of simple tasks to more advanced movement patterns as follows: * Reaching activities 1. Forward supported reach with cane on tabletop 2. Reaching against gravity 3. Reaching overhead with active wrist/hand movements 4. Dynamic reaching to target e.g. catch a ball * Grasping, holding and release 1. Grasp, hold and release objects with gravity minimized 2. Pick up and move/release small objects on table 3. Pick up and move/release large objects without proximal support 4. Incorporate pinch grips in hold and release including stacking, lifting and overhead activity * Upper limb ADL 1. Brushing hair, putting on scarf 2. Opening bottles, turning off water tap 3. Writing, drawing 4. Folding of towels, hanging towels and setting table 5. Self-feeding

Task Related Training

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female aged 40-70 years
  • Middle cerebral artery (MCA) stroke
  • months after stroke
  • Mini-mental state examination (MMSE)more than 24
  • Modified Ashworth scale score between1 and 2

You may not qualify if:

  • Patients with multiple sclerosis, spinal cord injury or with other pre-existing neurological disorders.
  • Patients with orthopedic condition affecting upper extremity
  • Patients with contraindication to TENS, like skin damaged etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chandka Medical College Hospital

Larkana, Sindh, Pakistan

Location

MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mirza Obaid Baig, MSPT(NMR)

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

October 12, 2021

Study Start

June 26, 2021

Primary Completion

July 31, 2022

Study Completion

August 31, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)