An interventional study of Game-Based Electromyographic (EMG) Biofeedback Therapy and Sham Control in Defecation Disorder, sponsored by Kocaeli University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Kocaeli University · Not applicable, Interventional, and Treatment
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on the quality of life and sleep quality of individuals diagnosed with dyssynergic defecation.
This study aimed to investigate the effects of game-based electromyographic (EMG) biofeedback therapy on quality of life, sleep quality, constipation severity, and pelvic floor muscle function in individuals diagnosed with dyssynergic defecation and chronic constipation. Dyssynergic defecation is a common functional defecation disorder and is one of the leading causes of chronic constipation. It is characterized by paradoxical contraction or inadequate relaxation of the pelvic floor muscles and anal sphincters during defecation, resulting in impaired evacuation of the rectum. This condition leads to excessive straining, a sensation of incomplete evacuation, prolonged stool retention, and significant deterioration in quality of life. Epidemiological studies indicate that dyssynergic defecation accounts for a substantial proportion of chronic constipation cases referred to tertiary care centers for treatment. In patients with dyssynergic defecation, pharmacological treatments alone are often insufficient because they do not address the underlying neuromuscular coordination disorder. Therefore, contemporary management strategies emphasize behavioral and rehabilitative interventions aimed at retraining pelvic floor muscle coordination in women with UI. Among these approaches, EMG biofeedback therapy has emerged as one of the most effective and evidence-based treatment modalities for this condition. Previous randomized controlled trials have demonstrated that EMG biofeedback improves defecation dynamics, reduces constipation-related symptoms, and provides sustained benefits compared with conventional treatment. Despite its proven efficacy, conventional EMG biofeedback therapy may be limited by reduced patient motivation, difficulty in understanding abstract muscle activity patterns, and decreased adherence. In recent years, game-based biofeedback systems have been introduced to overcome these limitations by enhancing patient engagement and facilitating the motor learning process. Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance in patients. Another important but often overlooked consequence of chronic constipation and dyssynergic defecation is the impaired sleep quality. Persistent abdominal discomfort, bloating, and defecation-related anxiety can negatively affect sleep patterns, leading to fatigue, reduced daytime functioning, and further deterioration in quality of life (QoL). However, limited data are available on the effects of pelvic floor rehabilitation and biofeedback therapy on sleep quality in this patient population. In recent years, increasing attention has been given to the role of objective physiological assessments in evaluating the efficacy of treatments. Anorectal manometry provides quantitative information on anorectal motility and pelvic floor muscle coordination and is considered the gold standard for diagnosing of dyssynergic defecation. The inclusion of objective manometric measurements alongside patient-reported outcomes allows for a comprehensive evaluation of both the clinical and physiological responses to treatment. Therefore, this randomized controlled study aimed to evaluate the short- and mid-term effects of game-based EMG biofeedback therapy, applied in addition to standard pelvic floor rehabilitation, compared with sham EMG biofeedback in individuals with dyssynergic defecation. The primary outcome of this study was the change in quality of life, assessed using the Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaire. Secondary outcomes included sleep quality, constipation severity, defecation patterns, pain intensity, pelvic floor muscle function assessed using surface EMG, and anorectal motility evaluated using anal manometry. By combining subjective clinical scales with objective physiological measurements, this study aimed to provide high-quality evidence regarding the effectiveness of adaptive, game-based EMG biofeedback therapy in the management of dyssynergic defecation. The findings are expected to contribute to the development of patient-centered, motivation-enhancing rehabilitation strategies and support the integration of game-based biofeedback approaches into standard pelvic floor rehabilitation programs.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 36 is below the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →Kocaeli University is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the experimental group will receive game-based electromyographic (EMG) biofeedback therapy in addition to the standard pelvic floor rehabilitation program.
Device: Game-Based Electromyographic (EMG) Biofeedback Therapy
Participants in the control group will receive sham EMG biofeedback therapy alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration.
Device: Sham Control
Game-based biofeedback integrates real-time visual feedback with interactive tasks, allowing patients to actively control on-screen elements through appropriate muscle activation and relaxation. This approach supports motor learning principles, promotes neuromuscular adaptation, and may improve treatment compliance.
Sham EMG biofeedback therapy will be administered alongside the same standard pelvic floor rehabilitation program with identical session frequency and duration. Surface electrodes will be placed in the same anatomical locations; however, the biofeedback device will operate in demo mode, and visual feedback will not reflect actual muscle activity.
Patient Assessment of Constipation-Quality of Life Questionnaire
The Patient Assessment of Constipation-Quality of Life questionnaire is a validated and reliable patient-reported outcome measure developed to assess the impact of chronic constipation on the quality of life. The scale consists of 28 items grouped into four subdomains. * Physical Discomfort: Assesses constipation-related physical symptoms and bodily discomfort. * Psychosocial Discomfort: Evaluates the impact of the condition on emotional status, social functioning, and psychological well-being. * Worries and Concerns: Assesses anxiety, concerns, and illness-related perceptions associated with constipation. * Satisfaction: Evaluates patients' satisfaction with their current bowel function and treatments. Each item is scored on a 5-point Likert scale, with higher scores indicating a greater negative impact on the quality of life.
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index is a self-reported questionnaire that assesses sleep quality over 1-month period. The measure consists of 19 individual items, creating seven components that produce one global score, and takes 5-10 minutes to complete. Each item is weighted on a 0-3 interval scale. The global PSQI score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with lower scores denoting healthier sleep quality.
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Constipation Severity Instrument
Constipation severity will be evaluated using the Constipation Severity Instrument, which assesses the severity of constipation-related symptoms and their impacts on daily life. It uses a five-point Likert scale (0-4), resulting in a total score from 0-73, where higher scores indicate greater severity.
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Bristol Stool Scale
The Bristol Stool Scale categorizes human feces into seven types based on their shape and consistency, ranging from constipation (types 1-2) to diarrhea (types 5-7). This classification facilitates the objective monitoring of changes in bowel habits by assessing stool form and consistency.
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Visual Analog Scale
Pain intensity and defecation-related discomfort will be measured using the Visual Analog Scale, a widely used tool for quantifying subjective pain perception. It is resulting in a total score from 0-100 mm, where higher scores indicate severe pain.
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Anorectal manometry
Anorectal manometry is considered the gold standard for assessing anorectal function and for objectively monitoring physiological responses to treatment in patients with dyssynergic defecation.
Time frame: At baseline, immediately after the intervention, and 2-months after the intervention.
Plan to share: No
Started Mar 2026 (actual). Primary completion is estimated for Oct 2026, 7 months after the start.
Of 243 non-industry interventional studies with no phase under Constipation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 7 months is below that.
Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.
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